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Patient 1
DEVICE EVALUATION: AS RECEIVED, THE SPECIMEN CONSISTED OF ONE 300-014 GW, SHORT TAPER GUIDEWIRE; RETURNED COILED, LOOSE AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY BIOHAZARD POUCHES. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE SPECIMEN PRESENTED MULTIPLE KINKS/BENDS OF VARYING SEVERITY AND FREQUENCY SCATTERED OVER THE LENGTH OF THE SPECIMEN. THE SPECIMEN ALSO PRESENTED SCRAPED/FRAYED PTFE COATING IN A PROXIMAL TO DISTAL ORIENTATION, WITH COATING REMOVAL AND LOOSE PTFE, SCATTERED OVER THE COATED LENGTH. OUR INVESTIGATION WAS UNABLE TO CONFIRM THAT THE PRODUCT DID NOT MEET SPECIFICATION PRIOR TO SHIPMENT. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET SPECIFICATION AT THE TIME OF SHIPMENT. THE DAMAGE PRESENTED BY THE SPECIMEN APPEARS CONSISTENT WITH MANIPULATION AGAINST RESISTANCE. AS NOTED IN THE PRECAUTIONS PORTION OF THE THRUWAY DEVICE INSTRUCTIONS FOR USE, "DO NOT TORQUE, ADVANCE OR WITHDRAW THE GUIDEWIRE IF SIGNIFICANT RESISTANCE IS FELT. TORQUEING, ADVANCING OR WITHDRAWING A GUIDEWIRE AGAINST SIGNIFICANT RESISTANCE MAY CAUSE VESSEL DAMAGE, GUIDEWIRE DAMAGE AND/OR GUIDEWIRE TIP SEPARATION." AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT CLINICAL AND/OR PROCEDURAL FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED. THE PATIENT INFORMATION WAS NOT PROVIDED AT THE TIME OF THIS REPORT. IF THERE IS ANY FURTHER RELEVANT INFORMATION PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE FILED.