UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001

November 24, 2003

NRC INFORMATION NOTICE 2003-21: HIGH-DOSE-RATE-REMOTE-AFTERLOADER 

EQUIPMENT FAILURE

Addressees:

All medical licensees.

Purpose:

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

addressees of a recently reported medical event that occurred during the conduct of a highdose-rate-remote-afterloader (HDR) brachytherapy procedure. The medical event involved

error in selection of ancillary equipment--transfer tube--required for use of the HDR unit,

resulting in failure of the sealed source to reach its intended position for treatment, and failure of

the sealed source to retract on completion of the procedure.

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

operations and consider actions, as appropriate, to avoid similar problems. However,

suggestions contained in this IN are not new NRC requirements; therefore, no specific action

nor written response is required.

Description of Circumstances:

An Agreement State licensee reported that a 170.2 gigabecquerel (4.6 curie) iridium-192 sealed

source contained in a Nucletron MicroSelectron HDR afterloader device--Model Number 31324-

-failed to retract on completion of a patient treatment. The physicist entered the treatment room

and attempted to manually retract the sealed source, which was stuck in the transfer tube, the

source conveyor device between the HDR unit and the applicator used for the procedure. 

Manual retraction of the sealed source failed. The physician entered the treatment room,

disconnected the apparatus from the patient, and dropped the transfer tube into a lead

container. Both the physicist and physician then moved the patient out of the room. The

physicist observed that 2 minutes had elapsed since he entered the treatment room. The

physicist surveyed the patient with a radiation detection instrument to confirm that the source

had been removed. The physicist then re-entered the room to perform a radiation survey. He

confirmed that the source was within the transfer tube and that it was shielded by the lead

container. The physicist measured 0.1 millisievert (mSv)/hr at 0.91 meters [10 millirem

(mrem)/hr at 3 feet] from the shielded container. The room was locked and posted until the 

ML033250492
IN 2003-21 

Page 2 of 3

manufacturer's representative arrived. The manufacturer’s representative also was unable to

retract the source from the transfer tube into the HDR unit. He then disconnected the transfer

tube from the HDR unit, placed the transfer tube, containing the sealed source, into a shipping

container, and arranged for returned of the transfer tube to the manufacturer, for further

investigation.

 Doses to the patient, physicist, and physician (as originally reported) were estimated as follows:

(1) patient’s skin dose, at 10 centimeters (cm) [3.9 inches (in.)] from the sealed source, was

0.61 sieverts (Sv) (61 rem); (2) physicist’s whole-body dose (deep-dose equivalent), for the 2-

minute exposure, was 0.45 mSv (45 mrem); (3) physician’s whole-body dose (deep-dose

equivalent) was 1.25 mSv (125 mrem), and extremity dose was 0.15 Sv (15 rem).

The Agreement State and NRC are continuing to investigate this event. Because of the

importance to licensees of the information contained in this IN, it is being issued before

completion of the investigation of this event.

Discussion:

Although the transfer tube used was manufactured by Nucletron for use with the Nucletron

MicroSelectron HDR afterloader device, it was a rigid gynecological-type tube, not designed for

use with the Proxima Therapeutics Mammosite applicator being used by the licensee for the

procedure being performed. Nucletron indicated that the licensee should have used its flexible

transfer tube, approved for use for non-gynecological-type treatments, which is designed to

accommodate the Mammosite applicator.

As a result of the incorrect choice of transfer tube (i.e., an incorrect transfer tube being used

with the Mammosite applicator) during the procedure, the sealed source was inadvertently

positioned inside the transfer tube at a distance of 10-14 cm (3.9-5.5 in.) from the patient’s

breast, not in the breast, as planned. That is, the source of the radiation never arrived at the

intended treatment site within the patient’s body. Also, the use of the incorrect Nucletron

transfer tube for the Mammosite applicator apparently caused the subsequent failure of the

source to retract. 

Licensees performing HDR brachytherapy procedures are expected to review this IN and:

• Assure that ancillary devices to be used with an HDR brachytherapy unit for a

therapeutic procedure are designed for use with, or are known to be compatible with,

both the HDR afterloader unit and with any applicator(s) to be used during

the procedure;

• Assure that all HDR afterloader brachytherapy unit users are familiar with the operating

procedures and applicable usage restrictions of all equipment to be employed in a

procedure before actual use of such devices and ancillary equipment;

• Encourage device and equipment users to review all of the vendors’ pertinent

documentation and to clarify any concerns with the vendors, regarding particular

devices, before using the devices for patient treatments. If, based on prior review of a 
IN 2003-21 

Page 3 of 3

vendor’s documentation, and possibly discussion with a vendor, a user considers that

directions provided by an on-site vendor’s representative may perhaps be in error,

licensees are expected to clarify any such discrepancies with the manufacturer before

use of the device(s); and

• Promptly report all system malfunctions to the vendors, and if required, to the licensing

authorities.

This IN requires no specific action nor written response. If you have any questions about the

information in this notice, please contact the technical contact below, or the appropriate

regional office.

/RA/

Charles L. Miller, Director

Division of Industrial and

 Medical Nuclear Safety

Office of Nuclear Material Safety

 and Safeguards

Technical Contact: Ronald E. Zelac, Ph.D., NMSS

301-415-7635

e-mail: rez@nrc.gov 

Attachments:

1. List of recently issued NMSS Information Notices

2. List of recently issued NRC Information Notices
____________________________________________________________________________________

OL = Operating License

CP = Construction Permit

Attachment 1

IN 2003-21

Page 1 of 1

LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of 

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2003-20 Derating Whiting Cranes

Purchased Before 1980

10/22/2003 All holders of operating licenses

for nuclear power reactors, except

those who have permanently

ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel; applicable

decommissioning reactors, fuel

facilities, and independent spent

fuel storage installations.

2003-16 Icing Conditions Between

Bottom of Dry Storage System

and Storage Pad

10/06/2003 All 10 CFR Part 72 licensees and

certificate holders.

2003-12 Problems Involved in

Monitoring Dose to the Hands

Resulting from the Handling of

Radiopharmaceuticals

08/22/2003 All holders of 10 CFR Parts 32,

33, and 35 licenses.

2003-10 Criticality Monitoring System

Degradation at BWX

Technologies, Inc., Nuclear

Products Division, Lynchburg,

VA

08/04/2003 All U.S. Nuclear Regulatory

Commission (NRC) licensees

authorized to possess a critical

mass of special nuclear material.

2003-09 Source Positioning Errors and

System Malfunctions During

Administration of Intravascular

Brachtherapy

07/16/2003 All medical licensees.

Note: NRC generic communications may be received in electronic format shortly after they are issued by

subscribing to the NRC listserver as follows:

To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the

message portion:

subscribe gc-nrr firstname lastname
______________________________________________________________________________________

OL = Operating License

CP = Construction Permit

Attachment 2

IN 2003-21

Page 1 of 1

LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of 

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2003-20 Derating Whiting Cranes

Purchased Before 1980

10/22/2003 All holders of operating licenses

for nuclear power reactors, except

those who have permanently

ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel; applicable

decommissioning reactors, fuel

facilities, and independent spent

fuel storage installations.

2003-19 Unanalyzed Condition of

Reactor Coolant Pump Seal

Leakoff Line During Postulated

Fire Scenarios or Station

Blackout

10/06/2003 All holders of operating licenses

or construction permits for

pressurized water reactors

(PWRs).

2003-18 General Electric Type SBM

Control Switches With

Defective Cam Followers 

09/26/2003 All holders of operating licenses

for nuclear power reactors, except

those who have permanently

ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel.

2003-17 Reduced Service Life of

Automatic Switch Company

(ASCO) Solenoid Valves With

Buna-N Material

09/29/2003 All holders of operating licenses

for nuclear power reactors.

2003-16 Icing Conditions Between

Bottom of Dry Storage System

and Storage Pad

10/06/2003 All 10 CFR Part 72 licensees and

certificate holders.

Note: NRC generic communications may be received in electronic format shortly after they are

issued by subscribing to the NRC listserver as follows:

To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following

command in the message portion:

subscribe gc-nrr firstname lastname