BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2770608 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05926
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 5, 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

    AGE AT TIME OF EVENT 18 YEARS OR OLDER. (B)(4). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS TOTAL OCCLUSION OF THE LEFT ILIAC ARTERY. A MUSTANG 6.0 X 40, 75CM BALLOON CATHETER RUPTURED AT AN UNKNOWN ATM ON INITIAL INFLATION. THE MUSTANG BALLOON CATHETER WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171060470 0015257736

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: ST. JUDE MEDICAL