BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2992679 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01348
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 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). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE BALLOON MATERIAL WAS TORN LONGITUDINALLY FOR A DISTANCE OF APPROXIMATELY 50MM AT 14MM DISTAL TO THE PROXIMAL TRANSITION ZONE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ANOMALIES. 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 CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE VASCULAR ACCESS WAS OBTAINED VIA THE LEFT EXTERNAL ILIAC ARTERY USING A 6FR GUIDING SHEATH. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. AFTER PREDILATION WITH AN UNKNOWN BALLOON, A 6X8MM NON-BSC STENT WAS IMPLANTED. THEN THE PHYSICIAN ADVANCED A 8.0 X 40MM X 75CM MUSTANG BALLOON CATHETER TO THE IMPLANTED STENT. UPON THE FIRST INFLATION AT 10ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE VASCULAR ACCESS WAS OBTAINED VIA THE LEFT EXTERNAL ILIAC ARTERY USING A 6FR GUIDING SHEATH. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. AFTER PREDILATION WITH AN UNKNOWN BALLOON, A 6X8MM NON-BSC STENT WAS IMPLANTED. THEN THE PHYSICIAN ADVANCED A 8.0 X 40MM X 75CM MUSTANG BALLOON CATHETER TO THE IMPLANTED STENT. UPON THE FIRST INFLATION AT 10ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97868 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171080470 15472969

    Patients

    Seq Age Sex Outcome Treatment
    1