BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 6167493 · Received December 12, 2016

    Report

    Report Number
    2134265-2016-11411
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 24, 2016
    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 CONFIRMED THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE AND DEFLATED. NO ISSUES WERE NOTED WITH THE TIP SECTION OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT, SUBJECTED TO POSITIVE PRESSURE AND A BALLOON PINHOLE LEAK WAS IDENTIFIED AT THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUE WITH THE DISTAL AND PROXIMAL MARKERBANDS. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS OR DAMAGE ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 12.0 X 20, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 12.0 X 20, 75CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816297 MUSTANG¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171120270 0017785578

    Patients

    Seq Age Sex Outcome Treatment
    1