BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2972386 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00929
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE BALLOON MATERIAL WAS FULLY DEFLATED. THERE WAS DRIED BLOOD INSIDE THE DEFLATED BALLOON. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ANOMALIES. AN ATTEMPT TO INFLATE THE BALLOON FAILED DUE TO A PINHOLE LEAK LOCATED AT APPROXIMATELY 15MM PROXIMAL TO THE DISTAL TRANSITION ZONE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ILIAC ARTERY. THE PHYSICIAN ADVANCED A 8.0 X 20MM X 75CM BALLOON CATHETER TO THE TARGET LESION. UPON THE FIRST INFLATION AT 12ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED BY IMPLANTING AN UNKNOWN STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ILIAC ARTERY. THE PHYSICIAN ADVANCED A 8.0 X 20MM X 75CM BALLOON CATHETER TO THE TARGET LESION. UPON THE FIRST INFLATION AT 12ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED BY IMPLANTING AN UNKNOWN STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75825 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171080270 15673769

    Patients

    Seq Age Sex Outcome Treatment
    1