BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG GATEWAY OTW OUS 2.00MM X 9MM

    MDR report key: 4249905 · Received November 14, 2014

    Report

    Report Number
    3008853977-2014-00357
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    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

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE DEVICE REVEALED CRYSTALLIZED SUBSTANCE IN THE CATHETER, INFLATION LUMEN AND BALLOON. NO FRICTION WAS NOTED WHEN INSERTING A DEMONSTRATION GUIDEWIRE. DURING INFLATION TESTING, THE BALLOON WOULD NOT INFLATE, LIKELY DUE TO THE DRIED CRYSTALLIZED SUBSTANCE BLOCKING THE INFLATION LUMEN OF THE DEVICE. ULTIMATELY, AFTER SEVERAL ATTEMPTS THE BALLOON WAS ABLE TO INFLATE. DURING FUNCTIONAL TESTING, NO LEAKS WERE NOTED AND NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LEAK WERE NOTED. THE REPORTED COMPLAINT WAS NOT CONFIRMED BECAUSE NO LEAKS WERE NOTED AND BECAUSE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LEAK WERE FOUND. THE OBSERVED CRYSTALLIZED SUBSTANCE FOUND IN THE BALLOON LUMEN OF THE DEVICE LIKELY OCCURRED AFTER THE PROCEDURE BECAUSE A BLOCKED INFLATION LUMEN WAS NOT REPORTED OR MENTIONED AND BECAUSE THE DEVICE WAS USED (TYPICAL INFLATION MEDIA IS A SALINE/CONTRAST MIX) AND ALLOWED TO DRY. THERE IS NO INDICATION OF MISUSE, USER ERROR OR MISHANDLING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON, AN AIR LEAK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON, AN AIR LEAK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON, AN AIR LEAK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738534 FG GATEWAY OTW OUS 2.00MM X 9MM CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MINN 16232028

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR