Information Notice No. 95-50

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 UNITED STATES

 NUCLEAR REGULATORY COMMISSION

 OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

 WASHINGTON, D.C. 20555-0001

 October 30, 1995

NRC INFORMATION NOTICE 95-50: SAFETY DEFECT IN GAMMAMED 12i BRONCHIAL 

 CATHETER CLAMPING ADAPTERS

Addressees

All High Dose Rate Afterloader (HDR) licensees.

Purpose

The U.S. Nuclear Regulatory Commission is issuing this information notice to

alert addressees to the manufacturer's recommendation to discontinue use of

GammaMed 12i 1.8-millimeter(mm) bronchial catheter adapters. 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 information notice are not new NRC

requirements; therefore, no specific action nor written response is required.

Description of Circumstances

During a bronchial treatment, on November 16, 1994, using a GammaMed 12i HDR,

the bronchial catheter pulled out of the catheter clamping adapter. This

resulted in the clamping adapter clamping on the source wire, producing an

abnormally high amount of friction during subsequent source movement. On

detection of this interference to source movement, the device initiated an

emergency retract, thus terminating the patient treatment. During this

emergency retract, the source became stuck in the clamping adapter,

necessitating prompt emergency response, by the Radiation Oncology staff, to

evacuate the patient from the high radiation area. The staff's prompt action,

limited the excess whole body exposure to the patient to less than 

0.4 millisieverts (40 millirem). However, the HDR source and drive mechanisms

were damaged and required replacement.

On July 13, 1995, a similar incident occurred while vendor representatives

were performing the acceptance testing on a new GammaMed 12i. Again, the

source became stuck in the bronchial catheter clamping adapter after the

catheter had pulled loose from the adapter. In freeing the stuck source, the

vendor's Radiation Safety Officer received an estimated extremity dose of 

26 centigray (rads). No patient was involved in this incident.

Discussion

After the first incident in November 1994, Frank Barker Associates, Inc.,

provided all its GammaMed 12i customers with instructions for proper use of

the GammaMed 12i, 1.8-mm bronchial catheter and associated clamping adapter. 

This notification (Attachment 1) was provided in the form of a BARKER+ TECHTIP dated November 22, 1994.

9510240405. IN 95-50

 October 30, 1995

 Page 2 of 2

After the second incident in July 1995, Frank Barker Associates, Inc., issued

two more notifications, to its customers on the use of the 1.8-mm bronchial

catheter clamping adapters, Product Number 931-012. The first of these

(Attachment 2) was another BARKER+ TECH-TIP, dated July 18, 1995, which

advised customers to avoid the "end test" mode of operation with the white

1.8-mm bronchial catheter, as this mode will stretch the catheter and possibly

push the catheter out of the clamping adapter. This TECH-TIP goes on to

describe the sticking of the source, in the clamping adapter, should the

catheter be pushed out of the adapter. 

Frank Barker Associates, Inc. also held discussions with the NRC, regarding

radiation safety issues associated with the failure of the GammaMed 12i

devices to retract the source into its shielded safe after a bronchial

catheter has been pulled out of the clamping adapter. They subsequently sent

a letter dated August 18, 1995, (Attachment 3) to all 12i users, advising them

to discontinue use of these adapters. The letter further advised the users

that new clamping adapters were in production and would be provided to them in

October 1995. 

NRC is concerned about the possibility of ether patients or licensee staff

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UNITED STATES NUCLEAR REGULATORY COMMISSION
Information Notice No. 95-50

file:////acfnas/perm/netsite-docs/gpo5445/in95050.html[4/19/2018 10:59:29 AM]

receiving excessive exposures to radiation if an HDR source fails to retract.

Because of this documented defect in the GammaMed 12i bronchial clamping

adapters, all affected licensees are encouraged to follow the recommendations

of the device vendor, as contained in its letter of August 18, 1995. Any

licensee using this adapter to complete a course of treatment started before

the vendor's notification should exercise extreme caution.

This information notice requires no specific action nor written response. If

you have any questions about the information in this notice, please contact

the technical contact listed below or the appropriate regional office.

 /s/'d by DACool

 Donald A. Cool, Director

 Division of Industrial and 

 Medical Nuclear Safety

 Office of Nuclear Material Safety

 and Safeguards

Technical contact: Robert L. Ayres, NMSS

 (301) 415-5746

Attachments:

1. BARKER+ TECH-TIP, dated November 22, 1994

2. BARKER+ TECH-TIP, dated July 18, 1995

3. BARKER+ Letter, dated August 18, 1995

4. List of Recently Issued NMSS Information Notices

5. List of Recently Issued NRC Information Notices