BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY¿

    MDR report key: 2823092 · Received November 7, 2012

    Report

    Report Number
    2939204-2012-00323
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    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

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. MAGNIFIED INSPECTION CONFIRMED THAT THE INNER SHAFT WAS APPROPRIATELY SEATED IN THE HUB AND THERE WAS ADHESIVE PRESENT IN THE ADHESIVE CAVITY AS INTENDED. MAGNIFIED VIEW OF THE INNER SHAFT REVEALED A HOLE DIRECTLY ALIGNED WITH THE INFLATION PORT. NO OTHER DAMAGES OR IRREGULARITIES WERE OBSERVED. NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT DURING ASSEMBLY AND THE DEVICE IS TESTED FOR BALLOON INFLATION/DEFLATION PERFORMANCE WITH VACUUM DECAY TESTING. IT IS PROBABLE THAT THE DAMAGE TO THE INNER SHAFT MAY BE DUE TO A PERFORATION WITH A NEEDLE OR GUIDEWIRE DURING HANDLING OF THE DEVICE AT THE PREPARATION STAGE. THEREFORE, A ROOT CAUSE OF HANDLING DAMAGE HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER WAS OBSERVED TO BE LEAKING DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON CATHETER WAS OBSERVED TO BE LEAKING DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY¿ CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072409250 14950506

    Patients

    Seq Age Sex Outcome Treatment
    1