BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 1250526 · Received November 14, 2008

    Report

    Report Number
    2939204-2008-00577
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO REGARDING THE EVENT WAS REQUESTED AND THE FOLLOWING WAS DETERMINED: THE DEVICE WAS STORED AT THE DEVICE STOCKING CABINET LESS THAN 25C TEMPERATURE. THE POUCH WAS VISUALLY INSPECTED. NO DAMAGES WERE NOTED TO THE PACKAGING. THE CATHETER WAS REMOVED FROM THE PROTECTIVE HOOP AS PER DIRECTIONS FOR USE (DFU) WITH NO DIFFICULTIES. THE BALLOON CATHETER WAS NOT VISUALLY INSPECTED AFTER REMOVING FROM THE PROTECTIVE HOOP. THERE WERE NO AIR BUBBLES COMING OUT OF THE BALLOON DURING PURGING.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS NOTICED THAT THERE WAS SOME WATER LEAKING OUT FROM THE INFLATED BALLOON. THE PHYSICIAN SUGGESTED THAT THERE WAS "A CREVASSE ON THE BALLOON BODY." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER (GBA) OCCLUSION BALLOON GBA NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. 20724-0925 11799939

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR