MAMMOSITE RADIATION THERAPY SYSTEM
Received May 25, 2005 · Event occurred May 9, 2005
Report 610983 · MDR key 610983
Device
Generic name
Implant For Radiation Treatment
Model number
MAMMOSITE SPHERICAL VARIABLE 5-6 APPLICATOR TRAYCatalog number
*
Lot number
UNK
Product problems
- Balloon burst
- Replace
- Noise
- Defective Component
Patient
66 YR
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
THE PATIENT ARRIVED FOR SIMULATION OF THEIR PLANNED MAMMOSITE PROCEDURE. DURING THE SIMULATION, FLUOROSCOPY REVEALED THAT THE MAMMOSITE BALLOON HAD BURST. THE DOCTOR WAS NOTIFIED AND THE MD CAME AND REMOVED THE DEFECTIVE MAMMOSITE BALLOON. IT APPEARS TO HAVE BEEN A CLEAR TEAR. THE MD INSERTED A NEW MAMMOSITE BALLOON AND A SECOND SIMULATION WAS COMPLETED. A FEW DAYS LATER, THE PATIENT ARRIVED FOR THEIR FIRST TREATMENT. ON THE PRE-TREATMENT FLUOROSCOPY, THE REPLACEMENT MAMMOSITE BALLOON WAS FOUND TO HAVE BURST. THE PATIENT REPORTED HEARING A POPPING SOUND OVER THE WEEKEND. PHYSICIANS WERE NOTIFIED. BOTH PHYSICIANS RECOMMENDED REMOVING THE MAMMOSITE BALLOON AND NOT REINSERTING AT THIS TIME. THE TEAR IN THE BALLOON LOOKED CLEAN. THE WOUND WAS DRESSED AND THE PATIENT WAS ADVISED TO CONTINUE ON ANTIBIOTICS.