ML051780232

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555

June 23, 2005

NRC INFORMATION NOTICE 2005-17: MANUAL BRACHYTHERAPY SOURCE JAMMING 

ADDRESSEES

All medical licensees authorized to possess a Mick applicator.

PURPOSE

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to alert

addressees to recently reported medical events with ruptured seeds that have occurred at

different facilities during manual brachytherapy as a result of seed jamming. It is expected that

recipients will review the information for applicability to their facilities and consider actions, as

appropriate, to avoid similar problems. However, suggestions contained in this IN are not new

NRC requirements; therefore, no specific action or written response is required.

DESCRIPTION OF CIRCUMSTANCES

NRC has received ten medical event reports in the last five years, two of them recently,

involving the rupture of a jammed brachytherapy seed source while used in a

Mick Radio-Nuclear Instruments, Inc. Model Mick Applicator. However, there may be more

events with seeds containing accelerator-produced radioactive material that are not required to

be reported to the NRC. In one of the ten incidents reported, during the prostate brachytherapy

procedure, the cartridge containing seeds jammed in a Mick Applicator. When the licensee

attempted to dislodge the seed from the applicator, the seed ruptured. This caused radioactive

contamination to spread onto the applicator and surrounding surfaces. The applicator was

placed in a plastic bag and stored behind lead shielding in the hot laboratory. This description

is representative of all ten incidents.

Licensees’ corrective actions included procedure modifications, such as changes in handling of

the applicator and cartridge after the occurrence of a cartridge jam, and personnel training. 

DISCUSSION

In the ten events over the past five years, the cause of the seed rupture was excessive force

applied by the operator to the seed cartridge when trying to dislodge the jammed seed. The

force of pulling the cartridge out with the seed jammed is large enough to shear the seed and

cause contamination. The manufacturer, Mick Radio-Nuclear Instruments, Inc., is aware that

seed jamming may occur and provides instructions in the User Manual to follow when

attempting to dislodge the jammed seed. It is not apparent if the licensees involved in these

events followed the recommended procedure for dislodging jammed seeds. Attempting to force

the seed cartridge out of the applicator is contrary to the manufacturer’s instructions. Mick

Radio-Nuclear Instruments, Inc. recommends the following techniques to dislodge jammed

seeds:
IN 2005-17

Page 2 of 2

• Partially unscrew the head of the magazine (no more than one turn), thereby relieving

the downward pressure on the seeds. Please note that the magazine head and the 

cartridge are NOT designed or intended to be taken apart. This is only done to relieve 

the spring pressure on the seeds. Carefully attempt to remove the magazine from the

applicator.

• Flush the jammed seed out of the applicator using a light pressure water flush. This 

must be done over a collection pan situated such that all seeds are collected and

accounted for.

If the seeds cannot be removed safely, place the applicator in quarantine. The

applicator must be surveyed (for radiation) to determine if the broken seed has

contaminated the applicator.

If contaminated, the applicator must remain in quarantine for a minimum of 10

half-lives.

If clean, it is recommended that the applicator be returned to the manufacturer

for evaluation and repair/adjustment.

(Source: Mick 200–TPV Applicator Instruction Manual, Pg.15A, Form #:405-06; Rev. E;

4/15/05)

The State of Wisconsin has also identified the recent seed ruptures and has issued an IN on

the issue dated June 9, 2005. The Wisconsin IN is attached for your reference. 

This IN requires no specific action or written response. If you have any questions about the

information in this notice, please contact one of the technical contacts listed below.

/RA/

Charles L. Miller, Director

Division of Industrial and 

 Medical Nuclear Safety

Office of Nuclear Material Safety

 and Safeguards

Technical Contacts: Nima Ashkeboussi, NMSS John P. Jankovich, NMSS

(301) 415-7637 301-415-7904

E-mail: naa@nrc.gov E-mail: jpj2@nrc.gov 

Attachments: 1. State of Wisconsin Information Notice

2. List of Recently Issued NMSS Generic Communications

Note: NRC generic communications may be found on the NRC public Website,

http://www.nrc.gov, under Electronic Reading Room/Document Collections.
IN 2005-17

 Page 1 of 3 DIVISION O F PUBLIC HE ALTH

1 WEST W ILSON STREET

P O BO X 2659

 Jim Doyle MADISON W I 53701-2659

 Governor

State of Wisconsin 608-267-4797

 Helene Nelson FAX: 608-267-3695

 Secretary Department of Health and Family Services dhfs.wisconsin.gov

Attachment 1

INFORMATION NOTICE

TO: Department of Health and Family Services 

Radioactive Material Medical Use Licensees

FROM: Department of Health and Family Services 

Radioactive Materials Program

DATE: June 9, 2005

SUBJECT: Information Notice concerning MICK® Applicators

PURPOSE:

The Wisconsin Department of Health and Family Services is issuing this information notice to

inform medical use licensees of recent incidents involving jamming of the MICK® Applicator. It

is expected that recipients will review this information for applicability to their licensed activities

and consider actions, as appropriate, to avoid similar problems. Suggestions contained in this

Information Notice are not new DHFS requirements; therefore, no specific action or written

response is required. 

DESCRIPTION OF CIRCUMSTANCES

During the period of April 1, 2005 to June 1, 2005, the Department of Health and Family

Services became aware of two incidents in which a MICK® Applicator jammed resulting in a Pd103 seed being ruptured. 

In the first incident, the Radiation Oncologist after changing cartridges encountered resistance

when implanting the first seed. The Radiation Oncologist was then unable to insert the stylete

(i..e., plunger) more then a few millimeters when trying to implant the second seed. Upon trying

to remove the cartridge to investigate the problem, a Pd-103 brachytherapy prostate seed broke.

In the second incident, the Radiation Oncologist after changing cartridges encountered a similar

problem. The implantation needle became detached from the MICK® Applicator during the
IN 2005-17

Page 2 of 3

process of trying to install a new cartridge. After reattaching the implantation needle, the

Radiation Oncologist attempted to implant the first seed. However, the stylete would not insert

more then a few millimeters. The Radiation Oncologist then attempted to remove the cartridge

to investigate why the applicator had jammed. In the process of removing the cartridge, a Pd-103

brachytherapy prostate seed broke, resulting in the spread of contamination. 

In discussions with other licensees, the Nuclear Regulatory Commission and other Agreement

States, it was discovered that there have been other reported cases involving the MICK®

Applicator becoming jammed. In some cases, the licensees were able to get the applicators

working again and in other cases the prostate seeds have broken.

DISCUSSION

Failure to perform preventative maintenance on the MICK® Applicator may be the cause for

jamming incidents. Licensees are reminded that they should perform the manufacturer's

recommended preventative maintenance on the MICK® Applicator.

Licensees are also reminded not to screw cartridges into or out of the MICK® Applicator. Both

the reusable and disposable cartridges are designed to seat in the MICK® Applicator by simply

pushing them into the magazine receptor with a noticeable click. 

Licensees should also be aware that the 'Disposable MICK® Cartridge' maximum seed capacity is

15 seeds. The maximum seed capacity for the 'Reusable MICK® Cartridge' is 10 seeds. If

loading more then the maximum seed capacity, the applicator could jam. In addition, the

'Shielded / Disposable MICK® Magazines' are designed for one time use ONLY.

The MICK® web site at http://www.micknuclear.com contains information on dislodging

jammed seeds. An excerpt from the web site is included for your information.

This Information Notice requires no specific action or written response. If you have any question

about the information in this notice, please contact Cheryl K. Rogers at (608) 266-8135 or email

at rogerck@dhfs.state.wi.us or Jason Hunt at (608) 266-9443 or email at

huntjh@dhfs.state.wi.us.
Implant Sequence - (Continued)

Recommended

Useful Tips During the Implant Process:

When Loading the Magazine into the Applicator, ensure the Magazine sets into the Applicator properly, loading with

a noticeable “Click”.

Ensure the needle is properly connected to the Applicator. The needle should “CLICK” into the Needle Receptor and

should not disconnect unless the Needle Release Button is depressed.

During implantation, ensure the seed is completely advanced through the needle. Do not advance the seed partially

out of the cartridge and retract the Push-Wire Rod. This may cause the seeds to drop unevenly and seeds may

become jammed in the cartridge.

When loading Mick Magazines, visually check that the seeds are loaded straight and even in the cartridge. If the

seeds are placed askew in the cartridge, it may cause jamming during the implant procedure.

After an implant procedure, it is strongly recommended a physical seed inventory be performed to account for all

seeds.

Dislodging Jammed Seeds:

If and when a seed is jammed between the Applicator Needle Chuck and the Seed Cartridge, DO NOT force the seed

Magazine out of the Magazine receptor area of the Applicator. Undue pressure on the seeds may cause the seeds to

break or fracture.

The following techniques can be attempted:

 Partially unscrew the head of the magazine (no more than one turn), thereby relieving the downward

pressure on the seeds. Please note that the Magazine Head and the cartridge are NOT designed or intended

to be taken apart. This is only done to relieve the spring pressure on the seeds. Carefully attempt to remove

the Magazine from the Applicator.

 Flush the jammed seed out of the Applicator using a light pressure water flush. This must be done over a

collection pan situated such that all seeds are collected and accounted for. If the seeds cannot be removed

safely, place the Applicator in quarantine. The Applicator must be surveyed (for radiation) todetermine if

the broken seed has contaminated the Applicator.

If contaminated, the Applicator must remain in quarantine for a minimum of 10 half-lives.

If clean, it is recommended that the Applicator be returned to the manufacturer for evaluation and repair/adjustment.

Returning an Applicator for Service or Repair:

1. Call MRNI, Inc., Customer Service Tel. 914-667-3999 to obtain a “Return Authorization” number.

2. Mick Applicators (Instrument only) must be sterilized before sending to MRNI, Inc.

3. MRNI, Inc. will fax you form #414-10 to be completed by you (without the proof of a decontamination

form, your Mick Applicator will be returned unserviced).

Upon MRNI’s Receipt of Mick Applicator:

The Mick Applicator will be analyzed to determine the extent of the repair. We will then call the Contact Person to

get authorization for repair and cost before we commence with any work. The Mick Applicator will be returned prior

to your next case date.

-15A
Attachment 2

IN 2005-17

Page 1 of 1

Recently Issued NMSS Generic Communications

Date GC No. Subject Addressees

06/10/05 RIS-05-10 Performance-Based

Approach for Associated

Equipment in 10 CFR 34.20

All industrial radiography

licensees and manufacturers and

distributors of industrial

radiography equipment.

04/18/05 RIS-05-06 Reporting Requirements for

Gauges Damaged at

Temporary Job Sites

All material licensees possessing

portable gauges, regulated under

10 CFR Part 30.

04/14/05 RIS-05-04 Guidance on the Protection

of Unattended Openings

that Intersect a Security

Boundary or Area

All holders of operating licenses

or construction permits for nuclear

power reactors, research and test

reactors, decommissioning

reactors with fuel on site,

Category 1 fuel cycle facilities,

critical mass facilities, uranium

conversion facility, independent

spent fuel storage installations,

gaseous diffusion plants, and

certain other material licensees.

05/17/05 IN-05-013 Potential Non-conservative

Error in Modeling

Geometric Regions in the

Keno-v.a Criticality Code

All licensees using the Keno-V.a

criticality code module in

Standardized Computer Analyses

for Licensing Evaluation (SCALE)

software developed by Oak Ridge

National Laboratory (ORNL)

05/17/05 IN-05-012 Excessively Large Criticality

Safety Limits Fail to

Provide Double

Contingency at Fuel Cycle

Facility

All licensees authorized to

possess a critical mass of special

nuclear material.

04/07/05 IN-05-010 Changes to 10 CFR Part 71

Packages

All 10 CFR Part 71 licensees and

certificate holders.

Note: NRC generic communications may be found on the NRC public website,

http://www.nrc.gov, under Electronic Reading Room/Document Collections.