BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2071927 · Received April 28, 2011

    Report

    Report Number
    2939204-2011-00261
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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
    PHYSICIAN

    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 UNDER MAGNIFICATION FOUND THAT THE INNER SHAFT WAS CORRECTLY SEATED IN THE HUB AND ADHESIVE WAS PRESENT IN THE ADHESIVE CAVITY. IT WAS NOTED THAT THERE WAS A SMALL SLIT IN THE INNER SHAFT THAT DIRECTLY ALIGNED WITH THE INFLATION PORT. NO OTHER ANOMALIES WERE NOTED. THE DAMAGE TO THE INNER SHAFT MAY BE DUE TO PERFORATION WITH A NEEDLE OR GUIDEWIRE USED DURING THE PROCEDURE. NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT AND ALL DEVICES ARE TESTED FOR BALLOON INFLATION AND DEFLATION PERFORMANCE DURING MANUFACTURE. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS DUE TO HANDLING OF THE DEVICE IN THE PROCEDURE.

    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 3916230

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR