| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TRAXCESS 14 GUIDEWIRE | GUIDEWIRE | TERUMO CORPORATION, ASHITAKA | MOF | N/A | GW1420040 | 140718 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-21 | 0 |
Patient 1
THE USER FACILITY REPORTED A FOREIGN SUBSTANCE FOUND IN THE RHV (ROTATING HEMOSTATIC VALVE) OF THE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: A SCEPTER AND TRAXCESS DEVICE WAS BEING PREPARED; AND IT WAS THEN, THAT A LITTLE PIECE OF METAL WAS FOUND IN THE RHV.
Patient 1
THE ACTUAL SAMPLE ALONG WITH THE FOREIGN SUBSTANCE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTIONS OF THE FOREIGN SUBSTANCE CONFIRMED THAT THE SUBSTANCE WAS BLUE IN COLOR. THE SUBSTANCE WAS APPROXIMATELY 24MM IN LENGTH AND CONFIRMED BE PTFE (POLYTETRAFLUOROETHYLENE). THE OBTAINED SUBSTANCE WAS FOUND TO BE THAT OF THE SAME AS THAT OF THE CURRENT TRAXCESS SAMPLE. VISUAL INSPECTION OF THE ACTUAL SAMPLE DID NOT FIND ANY KINK OR DENT ON THE SHAFT. MAGNIFYING INSPECTION FOUND THAT THE ACTUAL SAMPLE HAD BEEN SHEARED OFF ON THE SEGMENTS AS FOLLOWS: APPROXIMATELY 1389 - 1413MM FROM THE DISTAL END (APPROXIMATELY 24MM); APPROXIMATELY 1800 - 1810MM FROM THE DISTAL END (APPROXIMATELY 10MM); AND APPROXIMATELY 1822 - 1853MM FROM THE DISTAL END (APPROXIMATELY 31MM). THE ACTUAL SHEARED OFF SECTIONS TOTALED, APPROXIMATELY 65MM IN LENGTH. THE LENGTH OF THE FOREIGN SUBSTANCE RETURNED MEASURED APPROXIMATELY 24MM. FROM THESE FINDINGS IT IS LIKELY THAT APPROXIMATELY 41MM IN LENGTH OF THE FOREIGN SUBSTANCE IS MISSING. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET MANUFACTURING SPECIFICATIONS. AN ATTEMPT WAS MADE TO INSERT THE ACTUAL SAMPLE INTO A FACTORY RESERVED SCEPTER SAMPLE. THE ACTUAL SAMPLE WAS FOUND TO BE INSERTED THROUGH THE SCEPTER ALONG THE TOTAL LENGTH WITH NO RESISTANCE BEING PERCEIVED OR NO SHEARING OF THE SHAFT BEING OCCURRED DURING ADVANCEMENT. REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# CONFIRMED THERE WERE NOT ANY INDICATIONS OF PRODUCTION RELATED PROBLEMS OR DISCREPANCIES IN THE INSPECTION RESULTS. A SEARCH OF THE COMPLAINT FILES CONFIRMED THAT THIS PRODUCT/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. SIMULATION TESTING WAS CONDUCTED. A FACTORY RETAINED TRAXCESS SAMPLE WAS LET TO COME IN CLOSE CONTACT WITH THE EDGE OF A METAL MADE OBJECT AND IN THIS STATE IT WAS PULLED IN THE PROXIMAL DIRECTION. THE SHAFT OF THE TRAXCESS SAMPLE GOT SHEARED OFF. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION PROVIDED BY THE USER FACILITY THE EVENT DESCRIPTION IT IS LIKELY THAT THE ACTUAL TRAXCESS SAMPLE WAS ABRADED WITH A RIGID OBJECT AND SHEARED OFF. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).