BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3981801 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04562
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SERIOUS/ HIGHLY TORTUOUS AND SERIOUS/ HIGHLY CALCIFIED LEFT ILIAC ARTERY. AN 8.0 X 40, 135CM MUSTANG¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO PREDILATE THE TARGET LESION. UPON AN UNSPECIFIED NUMBER OF INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY SEGMENT OF THE BALLOON DETACHED/ REMAINED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457719 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171080410 16948418

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR