BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCADE VCS CLOSURE DEVICE

    MDR report key: 22039081 · Received May 16, 2025

    Report

    Report Number
    MW5170509
    Event Type
    Other
    Date Received
    May 16, 2025
    Date of Event
    May 8, 2025
    Report Date
    May 12, 2025
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    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

    A 6/7 FR VASCADE CLOSURE DEVICE WAS USED AT THE RADIOFREQUENCY ABLATION FOR ACCESS CLOSURE. THE VASCADE DISC WAS DEPLOYED, SHEATH REMOVED, SLEEVE PUSH DOWN TO DEPLOY THE COLLAGEN PLUG, AT THE MOMENT OF PULLING BACK SLEEVE TO TAMPER DOWN THE PLUG, THE SLEEVE WAS STUCK, IT DID NOT WANT TO COME UP. THEY HAD TO ABORT THE DEPLOYMENT, CLOSE THE DISC AND PULL THE DEVICE OUT. MANUAL PRESSURE WAS HELD AT THE GROIN INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166678 VASCADE VCS CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB CARDIVA MEDICAL, INC. G580I250313A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention