BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STINGRAY LP

    MDR report key: 21300149 · Received February 3, 2025

    Report

    Report Number
    2124215-2025-04469
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729903352
    PMA / PMN Number
    K152401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K) #: K231176.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED CORONARY ARTERY. A STINGRAY LP BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STINGRAY BALLOON RUPTURED AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61772 STINGRAY LP CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H749393120SR0 0033732326 08714729903352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown