BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 852571 · Received May 18, 2007

    Report

    Report Number
    6000078-2007-00137
    Event Type
    Malfunction
    Date Received
    May 18, 2007
    Date of Event
    April 21, 2007
    Report Date
    April 21, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER IN 2007, THAT A CUSTOMER ENCOUNTERED PROBLEMS DURING USE OF A GUIDEWIRE. THE MICROCATHETER WAS APPROACHED TO THE ANEURYSM OF ANTERIOR COMMUNICATING ARTERY WITH THIS WIRE [DEVICE IN QUESTION]. THE CATHETER SLIPPED OUT FROM THE ANEURYSM DURING THE EMBOLIZATION. THEREFORE, THIS WIRE [DEVICE IN QUESTION] WAS ADVANCED THROUGH THE CATHETER IN AN ATTEMPT TO REPOSITION THE CATHETER. THEN, THE DISTAL END OF THE WIRE [DEVICE IN QUESTION] DID NOT MOVE UNDER THE FLUOROSCOPY. WHEN THIS WIRE [DEVICE IN QUESTION] WAS REMOVED FROM THE CATHETER, IT WAS NOTED THAT THE DISTAL END OF THE WIRE [DEVICE IN QUESTION] WAS FRACTURED. THE DISTANCE FROM THE DISTAL TIP OF THE MICROCATHETER TO ANTERIOR COMMUNICATING ARTERY WAS OBSERVED TO BE 10-15CM. A DISTAL LENGTH OF 10-15CM OF THE MICROCATHETER WAS PROTRUDED FROM THE GUIDING CATHETER. SINCE THE FRACTURED WIRE [DEVICE IN QUESTION] WAS CONTAINED IN THE MICROCATHETER, IT WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ANY COMPLICATIONS. A SECOND MICROCATHETER AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. STATUS OF PATIENT CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX 014/205 PLATINUM HAP: GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION 46-808 9257964

    Patients

    Seq Age Sex Outcome Treatment
    1 YR EXCELSIOR SL10 2M MICROCATHETER| TERUMO WIRE,| EXCELSIOR SL10 MICROCATHETER