BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 4151131 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-05937
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE TIP WAS DETACHED FROM THE SHAFT AT 6 MM PROXIMAL TO THE DISTAL END OF THE TIP. AN EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR WAS PRESENT ALONG THE MAIN BODY OF THE BALLOON FOR A DISTANCE OF 51 MM PROXIMALLY FROM THE DISTAL BALLOON BOND. THE BALLOON MATERIAL WAS ALSO TORN CIRCUMFERENTIALLY FOR APPROXIMATELY 2 MM AT THE DISTAL BALLOON BOND. EVIDENCE OF STRETCHING WAS VISIBLE AT THE DISTAL END OF THE BALLOON. AN EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES. THE BALLOON PROTECTOR WAS NOT RECEIVED FOR ANALYSIS. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR. IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS INFLATED AT 28 OR 29 ATMOSPHERES WHICH IS ABOVE THE RATED BURST PRESSURE AND THE BALLOON RUPTURED. THE DFU STATES; "DO NOT EXCEED THE RATED BALLOON BURST PRESSURE. THE RATED BURST PRESSURE IS BASED ON IN VITRO TESTING. AT LEAST 99.9 PERCENT OF THE BALLOONS WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE". (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT BALLOON RUPTURE AND BALLOON AND TIP DETACHMENT OCCURRED. POST PROCEDURE, A 10.0 X 40, 75CM MUSTANG¿ BALLOON CATHETER WAS TESTED FOR DILATATION OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN USED AN UNSPECIFIED INDEFLATOR AND INFLATED THE BALLOON AT 28 OR 29 ATMOSPHERES, THE BALLOON RUPTURED LONGITUDINALLY AND THE DISTAL PART OF THE BALLOON AND THE TIP WAS DETACHED FROM THE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS NOTED THAT BALLOON RUPTURE AND BALLOON AND TIP DETACHMENT OCCURRED. POST PROCEDURE, A 10.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS TESTED FOR DILATATION OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN USED AN UNSPECIFIED INDEFLATOR AND INFLATED THE BALLOON AT 28 OR 29 ATMOSPHERES, THE BALLOON RUPTURED LONGITUDINALLY AND THE DISTAL PART OF THE BALLOON AND THE TIP WAS DETACHED FROM THE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633279 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171090470 0016570872

    Patients

    Seq Age Sex Outcome Treatment
    1