BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE RX

    MDR report key: 10303981 · Received July 21, 2020

    Report

    Report Number
    3005099803-2020-02821
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 9, 2020
    Report Date
    July 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729283812
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUODENUM PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, IT WAS NOTED THAT A BLACK SLEEVE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764624 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00545900 0025479171 08714729283812

    Patients

    Seq Age Sex Outcome Treatment
    1