BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 3932603 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04191
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.   (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON DETACHMENT AND DEFLATION ISSUE OCCURRED. A 6.0 X 40, 75CM MUSTANG¿ BALLOON CATHETER WAS SELECTED. IT WAS NOTED THAT THE BALLOON GOT "STUCK" IN THE SHEATH FROM A NON-BSC DEVICE. THE BALLOON WOULD NOT DEFLATE ENOUGH TO COME OUT OF THE SHEATH. WHEN THE DEVICE WAS PULLED OUT, THE BALLOON STRIPPED OFF THUS THE ENTIRE SHEATH WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED SIZE MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409693 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171060470 0016982616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other