Description of Event or Problem · 1
GUIDEWIRE USED APPROPRIATELY BY INSERTION INTO PATIENT. AFTER MANIPULATION CORE WAS PULLED BACK ABOUT 2CM. AFTER GUIDE IN PLACE WIRE WAS STRAIGHTENED. DIFFICULTY WAS NOTED IN STRAIGHTENING. AFTER REMOVAL IT WAS NOTED CORE HAD EXTENDED THROUGH FRACTURE OF J. NO INJURY TO PATIENT. MANUFACTURER CALLED. SIMILAR DIFFICULTY WITH MOVEABLE CORE AND FRACTURE OF J NOITED ON PATIENT PRIOR TO THIS ONE. ALL WIRES TAKEN OUT OF SERVICEDEVICE 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. 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, A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, GUIDEWIRE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.