Information Notice No. 95-50: Safety Defect in Gammamed 12i Bronchial Catheter Clamping Adapters
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
All High Dose Rate Afterloader (HDR) licensees.
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.
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+ TECH-
TIP 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
NRC is concerned about the possibility of ether patients or licensee staff
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
Technical contact: Robert L. Ayres, NMSS
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
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