BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STINGRAY? LP

    MDR report key: 25332587 · Received May 29, 2026

    Report

    Report Number
    2124215-2026-28883
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    UDI-DI
    08714729903352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RUPTURE OCCURRED. THE CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND NON-TORTUOUS RIGHT CORONARY ARTERY. A STINGRAY LP CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS POSITIONED SUB-INTIMAL AND WAS INFLATED FOR THE FIRST TIME AT UNDER 3 ATM FOR UNDER 3 SECONDS, AT WHICH POINT A LOSS OF BALLOON PRESSURE WAS OBSERVED AND THE BALLOON LEAKED AND RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT IN ONE PIECE, WITH NO FRAGMENTS LEFT BEHIND. INTRAVASCULAR ULTRASOUND DETERMINED THERE WAS NO DAMAGE TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166312 STINGRAY? LP CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION H749393120SR0 0036405089 08714729903352

    Patients

    Seq Age Sex Outcome Treatment
    1