BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG GATEWAY OTW OUS 2.50MM X 9MM

    MDR report key: 3012751 · Received March 20, 2013

    Report

    Report Number
    3008853977-2013-00048
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    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. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE CATHETER WAS KINKED ON ITS PROXIMAL SHAFT 2.2CM DISTAL TO THE STRAIN RELIEF. MAGNIFIED INSPECTION OF THE RETURNED DEVICE FOUND THAT THE INNER SHAFT UNDER THE MANIFOLD APPEARED TO BE PERFORATED. SOME FRICTION WAS NOTED WHEN INSERTING A DEMO GUIDEWIRE. WATER WAS LEAKING OUT OF THE GUIDEWIRE PORT DURING THE LEAK TEST. NO ANOMALIES WERE NOTED WITH THE BALLOON PORTION OF THE DEVICE, WHICH WAS UNABLE TO BE INFLATED BECAUSE OF THE OBSERVED LEAK. ALL DIMENSIONS WERE WITHIN SPECIFICATION. FROM THE INFORMATION PROVIDED, PRODUCT ANALYSIS RESULTS, MANUFACTURING RECORDS AND TREND INFORMATION THERE WAS NO EVIDENCE OF ANY DESIGN, MATERIAL DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL DEVICES ARE VISUALLY INSPECTED FOR BALLOON INTEGRITY DURING MANUFACTURE. FURTHERMORE, ALL DEVICES ARE TESTED FOR LEAKING AND FOR BALLOON INFLATION/DEFLATION PERFORMANCE WITH LEAK TEST AND VACUUM DECAY MULTIPLE TEST (VDT) DURING MANUFACTURE. BASED ON THE INVESTIGATION, IT APPEARS POSSIBLE THAT THE GUIDEWIRE WAS INSERTED FORCEFULLY INTO THE GUIDEWIRE LUMEN OR INTO THE INFLATION LUMEN. THE PROBABLE CAUSE PREPARATION DAMAGE HAS BEEN ASSIGNED TO THE REPORTED EVENT DUE TO THERE WAS NO EVIDENCE OF DESIGN OR MANUFACTURING SPECIFICATION NON-CONFORMANCES WERE FOUND AND THE ISSUE OCCURRED WITHOUT DIRECT PATIENT CONTACT DURING PREPARATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    DURING PREPARATION AIR BUBBLES WERE COMING FROM THE BALLOON INDICATIVE THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION AIR BUBBLES WERE COMING FROM THE BALLOON INDICATIVE THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116414 FG GATEWAY OTW OUS 2.50MM X 9MM CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MINN 14360501

    Patients

    Seq Age Sex Outcome Treatment
    1