Description of Event or Problem · 1
PT ADMITTED 6/29/93 WITH GRADE IV SUBARACHNOID HEMORRHAGE. EMERGENCY VENTRICULOSTOMY PERFORMED WITH CODMAN VENTRICULAR CATHETER. ON 7/2/93, PATIENT PULLED OUT THE EXTRACRANIAL PORTION OF THE SHUNT TUBE WHICH BROKE AND PART OF IT WAS LEFT IN THE PATIENT'S LEFT FRONTAL HORN. A CT SCAN WAS PERFORMED SHOWING NO ADVERSE CONSEQUENCE RELATIVE TO THE INCIDENT. SEVERAL DAYS FOLLOWING THE INCIDENT, THE PATIENT WAS DETERMINED BRAIN DEAD, CODED AND EXPIRED. THE PATIENT'S EXPIRATION WAS NOT RELATIVE TO THE PATIENT PULLING OUT THE CATHETER.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.