Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. UPON INSPECTION OF THE RETURNED SAMPLE, THE DISTAL END OF THE BALLOON AND A LARGE PORTION OF THE TIP MATERIAL UNDER THE BALLOON WAS MISSING AND WAS NOT RETURNED. THE TIP MATERIAL DETACHED JUST DISTAL OF THE PROXIMAL MARKER BAND. THE BALLOON HAD A "STAIRSTEP" TYPE SEPARATION IN THAT THE FAILURE MODE STARTS CIRCUMFERENTIALLY, TRANSITIONS TO LONGITUDINAL AND THEN TRANSITIONS BACK TO THE CIRCUMFERENTIAL AT THE ENDING POINT. THERE WAS NO VISUAL DAMAGE ON THE SHAFT OR TO THE BIFURCATE. DUE TO THE CONDITION OF THE SAMPLE FURTHER TESTING COULD NOT BE PERFORMED. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR A BALLOON RUPTURE, ROOT CAUSE UNKNOWN. IT IS UNKNOWN IF PT OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. THE CURRENT IFU (INFO FOR USE) STATES THE FOLLOWING: WARNING: IF RESISTANCE IS FELT WHEN EITHER REMOVING THE GUIDEWIRE FROM THE CATHETER OR THE CATHETER FROM THE INTRODUCER SHEATH, STOP AND CONSIDER REMOVING THEM AS A SINGLE UNIT TO PREVENT DAMAGE TO EITHER THE PRODUCTS OR THE VESSEL. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION. THE CURRENT IFU (INFORMATION FOR USE) INDICATES THE FOLLOWING: OPTI-PLAST XT PERIPHERAL BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR USE IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL VESSELS. BARD DOES NOT RECOMMEND THE USE OF THIS PRODUCT FOR PROCEDURES OTHER THAN THOSE MENTIONED ABOVE.