BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 15869502 · Received November 28, 2022

    Report

    Report Number
    3006232063-2022-00013
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    April 6, 2022
    Report Date
    November 28, 2022
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPANY REPRESENTATIVE WHO WAS PRESENT FOR THE IMPLANTATION PROVIDED IMAGES THAT SHOW THE IMPLANT WAS HITING AN OBSTRUCTION. THIS OBSTRUCTION CAUSED ADDITIONAL FORCE ON THE GUIDE WIRE WHICH SUBSEQUENTLY BROKE. THERE IS NO RISK TO THE PATIENT ACCORDING TO OUR HHA.

    Description of Event or Problem · 0

    INITIAL IMPLANTATION EXPERIENCED A GUIDEWIRE BREAK AND ALL PARTS WERE REMOVED AND A SECOND ATTEMPT WAS MADE TO IMPLANT A NEW DEVICE. THE SECOND ATTEMPT EXPERIENCED RESISTANCE AND WAS ABORTED WITHOUT ANY ISSUE. PATIENT WAS CLOSED WITHOUT A BARRICAID IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961386 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 04302118 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention