Description of Event or Problem · 1
DURING A PTCA PROCEDURE, A 10 FRENCH SHEATH WAS INSERTED TO LEFT FEMORAL ARTERY. WHILE THE PHYSICIAN WAS INSERTING A CATHETER INTO THE SHEATH, THE SHEATH CAME APART AT THE CLEAR HUB CONNECTION. A SMALL WHITE PLASTIC INTRODUCER REMAINED IN THE PATIENT AND HAD TO BE IMMEDIATELY REMOVED OVER A GUIDEWIRE. IN ADDITION, TWO OTHER SHEATHS CAME APART WHILE BEING REMOVED FROM TWO OTHER PATIENTS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.