BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASTEND MEDICAL SAFECROSS/ TRANSEPTAL RF PUNCTUR

    MDR report key: 16818178 · Received April 25, 2023

    Report

    Report Number
    MW5117065
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 24, 2023
    Manufacturer
    EAST END MEDICAL I LLC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT. IN CATH LAB FOR TEER PROCEDURE. SAFECROSS DEVICE USED FOR CROSSING INTRA-ATRIAL SEPTUM. SAFECROSS INSERTED - BALLOON TIP LEAKING. DEVICE REMOVED AND NEW DEVICE OPENED. DEFECTIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336707 EASTEND MEDICAL SAFECROSS/ TRANSEPTAL RF PUNCTUR INTRODUCER, CATHETER DYB EAST END MEDICAL I LLC. 3002 2208038

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male