BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRO-10 NEURO GUIDEWIRE

    MDR report key: 832134 · Received March 15, 2007

    Report

    Report Number
    6000078-2007-00078
    Event Type
    Death
    Date Received
    March 15, 2007
    Date of Event
    February 14, 2007
    Report Date
    February 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC-PRECISION VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    k032146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT BE RETURNED AS IT WAS NOT IMPLICATED IN THE SERIOUS INJURY LEADING TO THE PATIENT'S DEATH, AS IT WAS REMOVED PRIOR TO THE ISSUE. THE DEVICE WAS NOT REMOVED PRIOR TO THE COMPLICATION; HOWEVER, IT WAS NOT IN THE ARTERY THAT RUPTURED AND WAS NOT BEING MANIPULATED WHEN THE ARTERY RUPTURED. THE NON-BOSTON SCIENTIFIC BALLOON WAS THE DEVICE BEING MANIPULATED IN THE ACA AT THE TIME OF RUPTURE. THEREFORE, BASED SOLELY ON THE INFORMATION PROVIDED, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. THE CAUSE OF THE EVENT REMAINS UNKNOWN. K023700, K002907.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PRESENTED WITH AN ANTERIOR COMMUNICATING ARTERY (ACOM) THAT HAD PREVIOUSLY BEEN EMBOLIZED IN 2005. THE COILING HAD COMPACTED RESULTING IN A REOCCURRENCE OF THE ANEURYSMAL SAC. THIS PROCEDURE IN 2007 WAS INTENDED TO RE-EMBOLIZE THE SAC. THE PHYSICIAN UNSUCCESSFULLY TRIED FOR 35 MINUTES TO ACCESS THE ANTERIOR CEREBRAL ARTERY (ACA) WITH AN EXPEDITION 10 GUIDEWIRE AND HYPERFORM BALLOON. THE EXPEDITION WAS THEN SWITCHED OUT TO A SYNCHRO-10 GUIDEWIRE WHICH EASILY ACCESSED THE DISTAL A2 SEGMENT OF THE ACA. AFTER A FURTHER 10 MINUTES OF UNSUCCESSFUL ATTEMPTS, THE HYPERFORM BALLOON WAS FINALLY SUCCESSFULLY POSITIONED IN THE A2 ACA, BUT NEVER INFLATED. AT THE TIME OF THE BALLOON MANIPULATION, A CONTRAST INJECTION REVEALED AN ACTIVE INTRACRANIAL HEMORRHAGE AND A2 ACA RUPTURE RESULTING IN DEATH. IT WAS REPORTED THE SYNCHRO-10 GUIDEWIRE WAS NOT POSITIONED IN THE RUPTURED ARTERY, NOR WAS IT BEING MANIPULATED AT THE TIME. THE CAUSE OF THE INTRACRANIAL HEMORRHAGE REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO-10 NEURO GUIDEWIRE (DQX) GUIDEWIRE DQX BOSTON SCIENTIFIC-PRECISION VASCULAR 1631 B09201

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death HYPERFORM BALLOON (BOT PRODUCTS MADE BY MTI CORP.)| EXPEDION 10 MICROGUIDEWIRE AND| SYNCHRO 2 GUIDEWIRE| EXCEL 14 MICROCATHETER