Description of Event or Problem · 1
DURING CATHERIZATION THE PHYSICIAN NOTED DIFFICULTY WITH THE GUIDEWIRE. THIS GUIDEWIRE WAS PROMPTLY WITHDRAWN DUE TO DIFFICULTY. THE TEFLON SHEATH HAD A 2 CM LOO. THE GUIDEWIRE WAS NOT ABLE TO ADVANCE THROUGH THE LOOPED TEFLON SHEATH. THE LOOP DID REMAIN CONNECTED IN THE REMOVAL OF THE GUIDEWIRE AND SHEATH FROM THE PATIENT. THE PHYSICIAN STATED AND WAS OBSERVED TO NOT USE ANY ADDITIONAL FORCE IN USAGE. THE LOOP WAS LOCATED AT THE VERY TIP OF THE GUIDEWIRE. THE MANUFACTURER IS AWARE OF THE DIFFICULTY AND IS ARRANGING FOR EVALUATION OF GUIDEWIREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY FAILURE, UNANTICIPATED, GUIDEWIRE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.