Description of Event or Problem · 1
THE DISTRIBUTOR BECAME AWARE ON 6/24/93 OF AN INCIDENT THAT OCCURRED IN AUGUST OF 1992 INVOLVING A GLIDEWIRE GOLD. AN IDENTIFIED MIDDLE CEREBRAL FEEDER AVM AWAS TO BE EMBOLIZED WITH POLYVINYL ALCHOL PRE SURGICAL EXCISION. AFTER ENTERING THE MIDDLE CEREBRAL ARTERY A TEST INJECTION OF AMYTAL EFFECTED THE EXPECTED RIGHT SIDED PARALYSIS. HOWEVER, THE PARALYSIS DID NOT ABATE AND FURTHER INVESTIGATION EVIDENCED A VERY SMALL MIDDLE CEREBRAL ARTERIAL BLEED. IT IS BELIEVED THE GLIDEWIRE PERFORATED THE ARTERY. SEVERAL DAYS LATER THE PATIENT UNDERWENT A SUCCESSFUL UNEVENTFUL SURGICAL EXCISION OF THE AVM. A RESIDUAL OF FOOT DROP WAS THE POST OPERATIVE SEQUELAE. THIS IS BELIEVED TO BE A RESULT OF THE SURGERY AND NOT THE GLIDEWIRE INCIDENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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 NOT USED AS LABELED/INDENDED.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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.