Description of Event or Problem · 1
THE DISTRIBUTOR BECAME AWARE ON 6/24/93 OF AN INCIDENT THAT OCCURRED APPROXIMATELY SIX WEEKS AGO INVOLVING A GLIDEWIRE GOLD. AN IDENTIFIED TWO (2) FEEDER AVM WAS TO BE AEMBOLIZED PRE SZURGERY USING POLYVINYL ALCHOL. ONE FEEDER, THE MIDDLE CEREBRAL ARTERY WAS SUCCESSFULLY EMBOLIZED WITHOUT INCIDENT. WHILE ATTEMPTING TO GAIN PURCHASE IN THE POSTERIOR CEREBRAL ARTERY SOME DIFFIULTY WAS ENCOUNTERED. A TEST INJECTION OF CONTRAST FOR FLUOROSCOPIC VIEWING EVIDENCED EXTRA VASATION OF CONTRAST MEDIUM INTO THE PARENCHYMA OF THE BRAIN. IT IS BELIEVED THE GLIDEWIRE PERFORATED THE POSTERIOR CEREBRAL ARTERY. THE PATIENT BECAME SYMPTOMATIC DEVELOPING APHASIA. SURGICAL EXCISION OF THE AVM SEVERAL DAYS LATER WAS SUCCESSFUL AND UNEVENTFUL. A FULL RECOVERY WAS EXPERIENCED BY THE PATIENT WITH NO RESIDUAL APHASIA OR OTHER SYMPTOMSDEVICE 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.