BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3951006 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04233
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 PACKAGE SEAL WAS COMPROMISED. A 5.0 X 40, 75CM MUSTANG¿ BALLOON CATHETER WAS SELECTED. DURING UNPACKING, IT WAS NOTED THAT THE PACKAGE WAS ALREADY OPENED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428316 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171050470 016543999

    Patients

    Seq Age Sex Outcome Treatment
    1