BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 20753647 · Received November 21, 2024

    Report

    Report Number
    2124215-2024-73423
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 5, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729794349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. E1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. G4 PREMARKET / 510(K) #: K103751, K110122.

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. E1 INITIAL REPORTER FACILITY NAME: (B)(6). G4 PREMARKET / 510(K) #: K103751, K110122. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE OF 24 ATM 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. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO DAMAGE TO THE TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON SECOND INFLATION AT 18 ATMOSPHERES FOR 4 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST UPON SECOND INFLATION AT 18 ATMOSPHERES FOR 4 SECONDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778290 MUSTANG STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171040670 0030233872 08714729794349

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown