BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2834458 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06884
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 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

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. AN EXAMINATION OF THE RETURNED DEVICE IDENTIFIED A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR STRETCHED FROM THE DISTAL MARKERBAND AND IT EXTENDED PROXIMALLY ALONG THE BALLOON FOR 2.5CM IN LENGTH. AN EXAMINATION OF THE MARKERBAND IDENTIFIED NO ISSUES. 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 RUPTURED OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT BRACHIAL VEIN WITH A 5F INTRODUCER SHEATH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS LEFT BRACHIAL VEIN. THE 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS USED FOR DILATATION, UPON INFLATION AT 18 ATM THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE TO 20 ATM. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT POST PROCEDURE WAS LISTED GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURED OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT BRACHIAL VEIN WITH A 5F INTRODUCER SHEATH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS LEFT BRACHIAL VEIN. THE 7.0 X 40, 75 CM MUSTANG BALLOON CATHETER WAS USED FOR DILATATION. UPON INFLATION AT 18 ATMS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE TO 20 ATMS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT POST PROCEDURE WAS LISTED GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070470 0015376706

    Patients

    Seq Age Sex Outcome Treatment
    1 5F TERUMO INTRODUCER SHEATH| EVEREST INFLATION DEVICE| .035 RADIFOCUS GUIDEWIRE