BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG

    MDR report key: 21568972 · Received March 10, 2025

    Report

    Report Number
    2124215-2025-14688
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793342
    PMA / PMN Number
    K141521
    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) #: K141521, K141597.

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT G4 PREMARKET / 510(K) #: K141521, K141597.

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): FGE, LIT. G4 PREMARKET / 510(K) #: K141521, K141597. DEVICE EVALUATION BY MANUFACTURER: THE MUSTANG DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED 37MM IN LENGTH AND EXTENDED FROM A POSITION 1MM PROXIMAL OF THE PROXIMAL MARKERBAND TO 34MM DISTAL OF THE PROXIMAL MARKERBAND. A VISUAL AND TACTILE EXAMINATION OBSERVED NO DAMAGE OR KINK TO THE TIP AND SHAFT OF THE DEVICE. BOTH MARKERBANDS WERE UNDAMAGED AND PRESENT ON THE SHAFT OF THE DEVICE. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON POPPED AT LOW PRESSURE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL-CEPHALIC FISTULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON POPPED AT LOW PRESSURE. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON POPPED AT LOW PRESSURE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL-CEPHALIC FISTULA. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY CALCIFIED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150312 MUSTANG STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171070470 0034833108 08714729793342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown