BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 21840352 · Received April 15, 2025

    Report

    Report Number
    2124215-2025-23010
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K103751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    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. DETAILED PRODUCT INFORMATION WAS INCORRECTLY PROVIDED TO BSC. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE CORRECT BATCH OR LOT NUMBER, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. BECAUSE SOME OF THE SPECIFIC PRODUCT DETAILS ARE UNKNOWN, WE ARE UNABLE TO PROVIDE SOME OF THE SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON RUPTURED, AND THE DISTAL END SHEARED OFF AND HAD TO BE SNARED OUT OF THE PATIENT. A 4.0 X 40, 40CM MUSTANG BALLOON WAS SELECTED FOR DILATING A FOREARM DIALYSIS FISTULA. DURING THE PROCEDURE, THE BALLOON WAS TAKEN TO THE RATED BURST PRESSURE. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED, AND THE DISTAL END SHEARED OFF AND HAD TO BE SNARED OUT OF THE PATIENT. THE BALLOON WAS REPLACED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106313 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171040440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention