BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY PTA DILATION CATHETER

    MDR report key: 1230204 · Received July 30, 2008

    Report

    Report Number
    1230204
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 7, 2008
    Manufacturer
    NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP
    Product Code
    GBA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A MEDWATCH 3500A FORM REC'D FROM THE USER FACILITY REPORTING THE FOLLOWING EVENT TO THE MFR. THE PHYSICIAN HAD BEEN UNABLE TO INFLATE THE FIRST DILATION CATHETER AT THE LESION IN THE BASILAR ARTERY, DUE TO AN AIR LEAK, OUTSIDE THE PT, AT THE HUB. THE DEVICE WAS REMOVED AND A SECOND DILATION CATHETER [SUBJECT DEVICE] WAS ADVANCED TO THE LESION WITHOUT ISSUE. AS THE PHYSICIAN INFLATED THIS DEVICE, AIR BUBBLES WERE NOTED WITHIN THE BALLOON. THE BALLOON DID NOT RUPTURE, AND WAS SUCCESSFULLY DEFLATED, AND REMOVED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY PTA DILATION CATHETER (GBA) DILATATION BALLOON CATHETER GBA NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP 20722-2030 11409053

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR BOSTON SCIENTIFIC GATEWAY PTA DILATION CATHETER