BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2982587 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01710
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 LOWER LIMB ANGIOPLASTY PROCEDURE FOR TREATMENT, DIFFICULTY TO REMOVE THE CATHETER OCCURRED. A MUSTANG 5.0 X 40, 135CM CATHETER WAS USED TO PERFORM A LOWER LIMB ANGIOPLASTY. THE LESION WAS REPORTED TO BE A LONG LESION, WITH 65 TO 70% STENOSIS. THE BALLOON WAS INFLATED AT 24ATM FOR LESS THAN 10 SECONDS. INFLATION AND DEFLATION WERE EFFICIENT; THE BALLOON WAS FULLY DEFLATED WHEN TRYING TO REMOVE. ON WITHDRAWAL THE BALLOON JAMMED AND WAS DIFFICULT TO RE-ENTER THE SHEATH. SHEATH AND CATHETER WERE REMOVED TOGETHER. NO KINK WAS NOTICED ON THE SHEATH OR ON THE CATHETER ONCE REMOVED. THE DILATATION WAS REPORTED EFFECTIVE. THE LESION WAS LONG AND ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88427 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171050410

    Patients

    Seq Age Sex Outcome Treatment
    1