BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 3060534 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02344
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE RETURNED TO MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED. 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 FACTOR. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02466. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 100% STENOSED AND CALCIFIED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT COMMON ILIAC ARTERY. A NON BSC INTRODUCER SHEATH WAS USED. AFTER A NON BSC GUIDE WIRE WAS ADVANCED AND CROSSED THE LESION, A 3 MM X 20 MM MUSTANG¿ BALLOON WAS INFLATED AND IT RUPTURED AT 21 ATM DURING THE FIRST INFLATION. THEN A 3 MM X 20 MM X 135 CM MUSTANG BALLOON CATHETER WAS ADVANCED BUT THE BALLOON RUPTURED AT 15 ATM DURING THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162520 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171030270 0015201031

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO6F| GUIDEWIRE: TERUMO035