BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 4093455 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05535
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 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

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 BALLOON PINHOLE OCCURRED. THE 100% STENOSED CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION, A 5.0 X 150, 135CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED FOR PREDILATATION. HOWEVER, IT WAS NOTED THAT THE PRESSURE LEVEL DID NOT INCREASE DURING INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN INJECTED WATER INTO THE BALLOON AND A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571381 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171051510 15724228

    Patients

    Seq Age Sex Outcome Treatment
    1