TDC PA CATHETER

Additional Manufacturer Narrative

DIMENSIONAL AND PERFORMANCE TESTING WAS PERFORMED. THE RESULTS RECORDED NO NON-CONFORMANCES. THE DISTAL AND PROXIMAL LUMENS PASSED FUNCTIONAL SPECIFICATIONS. LEAK AND OCCLUSION TESTS WERE PERFORMED. THE RESULTS SHOW NO INTERLUMEN LEAKS. UNABLE TO REPLICATE OR IDENTIFY POTENTIAL CAUSES OF THE REPORTED DEFLATION PROBLEM. ADDITIONAL ANALYSIS: THOROUGH MICROSCOPIC ANALYSIS OF THE CATHETER BALLOON CONFIRMED THERE WERE NO MISSING BALLOON PIECES OR FRAGMENTS. THE BALLOON TEARS/DAMAGE OCCURRED WITH USER MANIPULATION IN ORDER TO DEFLATE AND REMOVE THE CATHETER. RECORD REVIEW: A REVIEW OF THE MFG LOT DATABASE FOR LOT# 84-815-YJ (MFG DATE 12/2009) SHOWS 118 UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. CONCLUSION: THE EXACT CAUSE OF THE REPORTED DEFLATION PROBLEM REMAINS UNK. THE DEVICE WAS SUCCESSFULLY PRE-TESTED AND INSERTED. THE MFR'S TESTING AND ANALYSIS OF THE RETURNED DEVICE FOUND NO OUT-OF SPEC CONDITIONS THAT WOULD CONTRIBUTE TO THE REPORTED EXPERIENCE. THE BALLOON TEARS/DAMAGE OCCURRED WITH USER MANIPULATION IN ORDER TO DEFLATE AND REMOVE THE CATHETER.

Description of Event or Problem

COMPLAINT RECEIVED REPORTING CATHETER BALLOON DEFLATION/DAMAGE (TORN) ISSUES INVOLVING ONE (1) 41231-06 TDC, 4L, 110CM PA CATHETER. INITIAL INCIDENT INFO RECEIVED REPORTED THAT ON (B)(6) 2001, DURING A RIGHT HEART CATHETERIZATION PROCEDURE, ATTENDING PHYSICIAN "WAS ABLE TO DO HIS PROCEDURE AND WEDGE THE BALLOON, HOWEVER, HE WAS UNABLE TO GET THE BALLOON DOWN AFTER OBTAINING WEDGE PRESSURES. WHEN HE DID GET THE BALLOON OUT OF THE PT, THE BALLOON HAD RUPTURED ALONG THE ROUTE SOMEWHERE. THE PHYSICIAN IS QUESTIONING "WHETHER OR NOT THE BALLOON RUPTURED INTO PIECES¿ PHYSICIAN THOUGHT IT WAS A REMOTE POSSIBILITY", VISUALLY INSPECTED THE DEVICE AND DID NOT APPEAR TO BE MISSING ANY PIECES. ADDITIONAL EVENT INFO: PT STATUS: PT DID NOT REQUIRE NOR RECEIVE ANY ADDITIONAL EMERGENT TREATMENTS/PROCEDURES. THE PT EXPERIENCED NO ADVERSE CONSEQUENCES AND WAS RELEASED FROM CATH LAB FOUR (4) HRS AFTER THE INCIDENT. THE CATHETER DEVICE WAS SUCCESSFULLY PRE-TESTED PER HOSPITAL PROTOCOLS WITH NO PERFORMANCE ISSUES/PROBLEMS NOTED. THERE WERE NO DIFFICULTIES DURING PLACEMENT. THE PROCEDURE WAS COMPLETED. THE 41231-06 CATHETER WAS RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION. VISUAL ANALYSIS OF THE RETURNED 41231-06 CATHETER RECORDED THE BALLOON WAS DAMAGED/TORN, THERE WAS A DARK SUBSTANCE INSIDE THE CATHETER BALLOON LUMEN. THE DARK SUBSTANCE/MATERIAL WAS ANALYZED AND FOUND TO BE BLOOD.