BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 20762203 · Received November 22, 2024

    Report

    Report Number
    2124215-2024-72913
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    September 25, 2024
    Report Date
    November 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729793380
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): LIT. G4 - PMA/510(K) # FIELD ON 3500A FORM: K103751, K110122, K141521.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): LIT. G4 - PMA/510(K) # FIELD ON 3500A FORM: K103751, K110122, K141521.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INFLATION AND DEFLATION ISSUES OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. TWO OR THREE ATTEMPTS WERE MADE TO INFLATE THE BALLOON. THE BALLOON WAS NOT INFLATED UNTIL 8-10 ATMOSPHERES. THE BALLOON WAS UNABLE TO FULLY INFLATE NOR DEFLATE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT IT WAS FULLY REMOVED AS IT WAS NOT ABLE TO INFLATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INFLATION AND DEFLATION ISSUES OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. TWO OR THREE ATTEMPTS WERE MADE TO INFLATE THE BALLOON. THE BALLOON WAS NOT INFLATED UNTIL 8-10 ATMOSPHERES. THE BALLOON WAS UNABLE TO FULLY INFLATE NOR DEFLATE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600320 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS LIT BOSTON SCIENTIFIC CORPORATION H74939171062010 0032593223 08714729793380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown