Description of Event or Problem · 1
AS CARDIOLOGIST WAS INTRODUCTING VENOUS SHEATH INTO FEMORAL VEIN, A KINK WAS EVIDENT IN THE MID-SHAFT. WHEN PHYSICIAN ATTEMPTED TO REMOVE SHEATH, THE DISTAL PORTION OF THE SHEATH "SHEARED OFF" WITH A FRAGMENT OF THE SHEATH REMAINING IN THE PATIENT'S RIGHT FEMORAL VEIN. AN IVC FILTER WAS PLACED IN PATIENT'S VENA CAVA TO PREVENT MIGRATION OF SHEATH FRAGMENT.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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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.