TOTAL ABSCESSION

Description of Event or Problem

THIS WAS A TIGHT BILE DUCT (2MM) THAT HE KNEW WOULD BE TOUGH. THEY GOT ACROSS THE DUCT WITH A ROADRUNNER, THEN EXCHANGED TO A LUNDQUIEST WIRE. HE BALLOONED DUCT AND THEN ADVANCED THE DRAIN OVER WIRE (WITHOUT PLASTIC CANNULA INSIDE FOR ADDED SUPPORT). HE TRIED TO PULL HARD ON THE WIRE ONLY, THEN ON BOTH THE WIRE AND CANNULA, BUT NOTHING WORKED. HE ENDED UP HAVING TO CUT EVERYTHING AND THEN PULL IT OUT. THEY ONLY SAVED THE DISTAL 15-20 CM OR SO. THE LEAD TECH TRIED TO PULL THE PLASTIC CANNULA OUT OF THE DRAIN POST-PROCEDURE, BUT IT WOULD NOT COME OUT AND SEEMED STUCK IN THE TIP OF THE DRAIN.

Additional Manufacturer Narrative

LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING FOUND THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT. REVIEW OF THE RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE FOLLOWING WAS OBSERVED: A CATHETER SECTION 19CM IN LENGTH WAS RETURNED WITH THE SUTURE WIRE AND CANNULA INSIDE. THE CANNULA WAS CLAMPED AND PULLED IN AN ATTEMPT TO REMOVED THE CANNULA FROM THE CATHETER. THE CATHETER TIP ACCORDION/BUNCHED UP NOT ALLOWING THE CANNULA TO RETRACT FROM THE CATHETER. WHILE HOLDING THE DISTAL TIP OF THE CATHETER SO THAT IT COULD NOT BRUNCH UP, THE CANNULA WAS PULLED FROM THE CATHETER WITHOUT DIFFICULTY. CONCLUSION: THE COMPLAINT INVESTIGATION IS CONFIRMED. THE COMPLAINT SAMPLE RETUNED FOR EVALUATION INCLUDED A 19CM SECTION OF DRAINAGE CATHETER WITH THE PLASTIC CANNULA STUCK INSIDE. WHEN PULLING ON THE CANNULA TO REMOVE IT FROM THE CATHETER, THE CATHETER TIP ACCORDION/BUNCHED UP. WHEN HOLDING THE DISTAL TIP SO, THE CATHETER COULDN'T BUNCH UP, THE CANNULA PULLED OUT WITHOUT DIFFICULTY. THE EXACT CAUSE OF THE COMPLAINT IS UNK. THE PATIENT'S CONDITION OR TOO MUCH FRICTION BETWEEN THE CANNULA AND CATHETER COULD HAVE CAUSED THE REPORTED COMPLAINT TYPE OR IF THE CANNULA LENGTHY PROVIDED INADEQUATE FIT WITH SHAFT. THE ACTUAL LENGTH OF THE CANNULA CANNOT BE VERIFIED SINCE ONLY A PORTION OF THE CANNULA WAS RETURNED FOR EVALUATION. THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE POSSIBLE LOTS WERE MANUFACTURED AND RELEASED TO SPECIFICATION. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.