BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 3963101 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04341
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AV DIALYSIS GRAFT OF THE LEFT ARM. A 8.0 X 80, 75CM MUSTANG¿ BALLOON WAS ADVANCED TO DILATE THE LESION. DURING PROCEDURE, THE BALLOON RUPTURED CIRCUMFERENTIALLY AT 20 ATMOSPHERES, THE PROXIMAL HALF OF THE BALLOON WAS STILL INTACT WITH THE CATHETER BUT THE DISTAL HALF OF THE BALLOON REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED BUT DUE TO THE FRAGMENTS LEFT IN THE BODY, THE PATIENT WAS SENT FOR SURGERY TO GET IT REMOVED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441082 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171080870 16973157

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention