BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2030002 · Received March 25, 2011

    Report

    Report Number
    2939204-2011-00156
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INSPECTION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE BALLOON OR THE DISTAL TIP OF THE DEVICE. A 0.014 INCH DEMONSTRATION GUIDEWIRE WAS INSERTED INTO THE DEVICE AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WITH WATER. ATTEMPTS TO INFLATE THE DEVICE TO NOMINAL PRESSURE WERE UNSUCCESSFUL. THE STRAIN RELIEF WAS CAREFULLY REMOVED TO EXPOSE THE PROXIMAL END OF THE INNER SHAFT. MAGNIFICATION INSPECTION CONFIRMED THAT THE INNER SHAFT WAS APPROPRIATELY SEATED IN THE HUB AND ADHESIVE PRESENT IN THE ADHESIVE CAVITY. MAGNIFIED VIEWS OF THE INNER SHAFT THROUGH THE INFLATION PORT IN THE HUB REVEALED SMALL SLIT IN THE INNER SHAFT DIRECTLY ALIGNED WITH THE INFLATION PORT. THE DAMAGE TO THE INNER SHAFT MAY BE DUE TO PERFORATION WITH A NEEDLE OR GUIDE WIRE. NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT DURING CATHETER ASSEMBLY. FURTHERMORE, ALL DEVICES ARE TESTED FOR BALLOON INFLATION/DEFLATION PERFORMANCE WITH VACUUM DECAY TESTING DURING MANUFACTURE. FROM THE INFORMATION PROVIDED AND THE INVESTIGATION IT WAS DETERMINED THAT HANDLING DAMAGE WAS THE MOST LIKELY CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072409200 13666888

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR