1.5MM GUIDE WIRE

Additional Manufacturer Narrative

ONE 72202189 1.5MM GUIDE WIRE USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, CONCLUSIONS, INVESTIGATION AND EVALUATION WERE LIMITED. IF OBJECTIVE EVIDENCE, RELEVANT INFORMATION, PACKAGING OR PRODUCT BECOMES AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT WILL CERTAINLY BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, IMPLANT LOCATION AND TISSUE CONDITION. REVIEW OF INSTRUCTION FOR USE DOCUMENTATION CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. THE COMPLAINT DISSATISFACTION POINTS TO THE PERFORMANCE OF A PROTECTIVE CAP USED DURING PACKAGING VS. THE ACTUAL GUIDEWIRE PRODUCT SOLD. ROOT CAUSE WAS FOUND TO BE VENDOR BASED; INEFFICIENT MATERIAL CURING TIME. THE SITUATION WAS CORRECTED AND AN ACTION WAS TAKEN TO PURGE OLD STOCK OF THE SILICONE CAPS AND REPLACE THEM WITH A DIFFERENT STYLE PROTECTOR TO PREVENT THE ISSUE GOING FORWARD. THIS LOT WAS MANUFACTURED PRIOR TO THE ACTION.

Additional Manufacturer Narrative

H10. H3, H6: ONE 1.5 X 229MM GUIDEWIRE NOT USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THE COMPLAINT DISSATISFACTION POINTS TO THE PERFORMANCE OF A PROTECTIVE CAP USED DURING PACKAGING VS. THE ACTUAL GUIDEWIRE PRODUCT SOLD. THE PRODUCT WAS OPENED BUT WAS UNABLE TO BE USED. CUSTOMER MADE ATTEMPT TO REMOVE ONE SILICONE CAP. EVALUATION CONFIRMED THAT REMOVAL WAS EXTREMELY DIFFICULT FOR THESE CAPS. IT REQUIRED SCISSORS OR KNIFE INVOLVED WHICH STILL RESULTED WITH CAP MATERIAL BEING LEFT BEHIND. IN ADDITION, THE WIRE MAY BECOME BOWED IN THE PROCESS. ROOT CAUSE WAS DETERMINED TO BE MATERIAL RELATED; INEFFICIENT MATERIAL CURING TIME. THE EXISTING PRODUCT WAS PURGED. A SUPPLIER PROCESS IMPROVEMENT WAS CONDUCTED TO ELIMINATE THE CONDITION. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. DHR/BATCH/LOT REVIEW DID NOT INDICATE A CONDITION OR PRODUCT/PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION ALTHOUGH OCCURRENCES DROVE AN INVESTIGATION RESULTING WITH A SUPPLIER PROCESS IMPROVEMENT.

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THE PLASTIC CAP THAT IS ON GUIDE WIRE, LEFT PLASTIC DEBRIS ON THE WIRE WHEN IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.