BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG BALLOON DILATATION CATHETER

    MDR report key: 2201313 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03410
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS MFR#: 2134265-2011-03408, 2134265-2011-03409. IT WAS REPORTED THAT DURING A PERCUTANEOUS ANGIOPLASTY PROCEDURE THREE BALLOON RUPTURES OCCURRED. THE LESION WAS LOCATED IN A HEAVILY CALCIFIED, NON TORTUOUS SUPERFICIAL FEMORAL ARTERY. A MUSTANG 7.0 X 40, 135CM, A MUSTANG 6.0 X 150, 135CM AND A MUSTANG 6.0 X 200, 135CM ALL RUPTURED. NUMBER OF INFLATIONS AND TO WHAT ATMOSPHERES IS UNKNOWN. THE BALLOONS WERE ALL REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE BALLOONS WERE RUPTURING ON THE EDGES OF AN UNKNOWN STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070410 14435095

    Patients

    Seq Age Sex Outcome Treatment
    1