BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFECROSS TRANSSEPTAL SYSTEM

    MDR report key: 16645460 · Received March 29, 2023

    Report

    Report Number
    MW5116128
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 24, 2023
    Report Date
    March 27, 2023
    Manufacturer
    EAST END MEDICAL I LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IN CATH LAB FOR TMVR. SAFECROSS TRANSSEPTAL SYSTEM USED TO CROSS INTRA-ATRIAL SEPTUM. FIRST SAFECROSS DEVICE LEAKING AT BALLOON TIP. REMOVED FROM FIELD. SECOND DEVICE OPENED AND USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529048 SAFECROSS TRANSSEPTAL SYSTEM INTRODUCER, CATHETER DYB EAST END MEDICAL I LLC 303 2206002

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization