BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STINGRAY LP

    MDR report key: 21697720 · Received March 26, 2025

    Report

    Report Number
    2124215-2025-18679
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729903352
    PMA / PMN Number
    K152401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K152401, K231176.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON ISSUE OCCURRED. A STINGRAY LP WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THERE WAS A CONTRAST COMING OUT OF THE BALLOON AS IF IT HAD BURST. THERE WAS NO ISSUE WITH THE PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719523 STINGRAY LP CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H749393120SR0 0034745291 08714729903352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown