BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 21951800 · Received May 2, 2025

    Report

    Report Number
    2124215-2025-26762
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 9, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K141521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) #: K141521, K141597. DEVICE EVALUATED BY MANUFACTURER: THE MUSTANG DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. IT IS NOT KNOWN WHEN THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. 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 DAMAGE TO THE TIP OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) #: K141521, K14159.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS TORN. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 5.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE FRONT OF THE CATHETER TIP WAS SLIGHTLY TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS TORN. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 5.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE FRONT OF THE CATHETER TIP WAS SLIGHTLY TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905387 MUSTANG STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171050470 0034476583

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male