BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 2090422 · Received May 16, 2011

    Report

    Report Number
    2939204-2011-00267
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K964611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE LABELING FOUND THAT THE PATIENT OUTCOME OF DEATH IS LISTED IN THE DIRECTIONS FOR USE AS A POTENTIAL RISK ASSOCIATED WITH SUCH PROCEDURES. VISUAL INSPECTION CONFIRMED THAT ONLY 3 CM FROM THE DISTAL END OF THE WIRE WAS RECEIVED. DEVICE ANALYSIS OF THE FRACTURED SITE REVEALED THAT THE FRACTURE OCCURRED DUE TO A BENDING CYCLIC MOVEMENT. NO MATERIAL ANOMALIES WERE FOUND. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S OUTCOME WAS NOT RELATED DIRECTLY TO THE DEVICE BUT DUE TO MANIPULATION OF THE DEVICE DURING PROCEDURE. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GUIDEWIRE ADVANCEMENT INTO THE ANTERIOR COMMUNICATING ARTERY (ACA), THE TIP DETACHED WITHIN THE GUIDE CATHETER. THE GUIDE CATHETER AND GUIDEWIRE TIP WERE REMOVED TOGETHER. THE PATIENT WAS REPORTED TO HAVE SUFFERED A STROKE AND AGGRASTAT (DOSE UNKNOWN) WAS ADMINISTERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GUIDEWIRE ADVACEMENT INTO THE ANTERIOR COMMUNICATING ARTERY (ACA), THE TIP DETACHED WITHIN THE GUIDE CATHETER. THE GUIDE CATHETER AND GUIDEWIRE TIP WERE REMOVED TOGETHER. THE PATIENT WAS REPORTED TO HAVE SUFFERED A STROKE DURING GUIDEWIRE NAVIGATION AND AGRASTAT (DOSE UNKNOWN) WAS ADMINISTERED. IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 3 DAYS POST PROCEDURE (UNKNOWN DATE). THE CAUSE OF DEATH IS UNKNOWN; HOWEVER, THE PHYSICIAN DID NOT RELATE THE PATIENT'S OUTCOME DIRECTLY TO THE DEVICE, BUT DUE TO MANIPULATION OF THE GUIDEWIRE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M003468020 13858812

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R 6F GUIDER GUIDE CATHETER (BOSTON SCIENTIFIC)