BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2915767 · Received January 15, 2013

    Report

    Report Number
    2134265-2012-08444
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    IT WAS REPORTED THAT DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS LEFT CEPHALIC VEIN. USING A 5F SHEATH AND A NON-BSC GUIDE WIRE, THE PHYSICIAN ADVANCED A 6.0 X 40MM X 75CM MUSTANG BALLOON CATHETER TO THE TARGET LESION. THE BALLOON WAS INFLATED TO 12ATMS THEN 18ATMS AND UPON THE THIRD INFLATION AT 20ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22363 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171060470 15459588

    Patients

    Seq Age Sex Outcome Treatment
    1 .035 RADIOFOCUS GUIDE WIRE