BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2770648 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05910
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 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). AS THE DEVICE HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 100% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. AFTER THE NON BSC GUIDE WIRE CROSSED THE LESION THE MUSTANG 4.0 X 40, 135CM BALLOON WAS ADVANCED TO THE LESION. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT AN UNKNOWN ATMOSPHERE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 H74939171040410 15244869

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO| GUIDE WIRE: SJM, TERUMO| INFLATION DEVICE: BSC