BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 21542884 · Received March 6, 2025

    Report

    Report Number
    2124215-2025-14074
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793403
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET/510(K) #: K103751, K110122.

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) #: K103751, K110122. B1: UPDATED WITH PRODUCT PROBLEM. DEVICE EVALUATION BY MANUFACTURER: THE MUSTANG DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS TIGHTLY FOLDED WITH THE BALLOON PROTECTOR ON AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE RATED BURST PRESSURE FOR THIS DEVICE IS 24 ATMOSPHERES AS PER MUSTANG SPECIFICATION. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. THE BALLOON PROTECTOR WAS REMOVED, AND THE DEVICE WAS INFLATED TO ITS RATED BURST PRESSURE OF 24 ATMOSPHERES WITH NO LEAKS OR ISSUES NOTED. A VISUAL EXAMINATION OF THE MARKERBANDS IDENTIFIED NO ISSUES. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT AND TIP. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 4.0 X 40, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST JUST BEFORE THE PRESSURE REACHED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ABNORMALITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 4.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST JUST BEFORE THE PRESSURE REACHED. THE PROCEDURE WAS COMPLETED WITHOUT ANY ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486977 MUSTANG STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171040470 0031046171 08714729793403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown