BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 3081169 · Received April 26, 2013

    Report

    Report Number
    2134265-2013-02691
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    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 MFR: THE COMPLAINT 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A SHUNT IN THE CALCIFIED AND MODERATELY TORTUOUS CEPHALIC VEIN. A 5F TERUMO INTRODUCER SHEATH WAS INSERTED VIA ANTEROGADE APPROACH. AFTER THE GUIDE WIRE CROSSED THE LESION, THE PHYSICIAN USED A 6.0X40,40CM MUSTANG BALLOON CATHETER. UPON THE FIRST DILATATION, THE BALLOON RUPTURED AT 8 ATMS. THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181294 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171060440 15518312

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 5F TERUMO| GUIDEWIRE: 0.35 RADIFOCUS