BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 15872914 · Received November 28, 2022

    Report

    Report Number
    3006232063-2022-00012
    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
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE SURGEON NARRATIVE AND IMAGING, IT WAS CONFIRMED THAT MESH GUIDE DETACHMENT HAD OCCURRED DURING IMPLANTATION AND THAT THE FRACTURED MESH GUIDE REMAINED WITHIN THE IMPLANT AT THE CLOSE OF SURGERY. NO DEVIATIONS OR NON-CONFORMANCES WERE NOTED IN THE LOT HISTORY REVIEW. THE FLUOROGRAPHS PROVIDED EVIDENCE THAT THE POSITIONING OF THE DELIVERY INSTRUMENT ROTATED DURING THE IMPLANTATION. THIS CHANGE IN ORIENTATION MAY HAVE BEEN RELATED TO THE ROOT CAUSE FOR THE MESH GUIDE FRACTURE.

    Description of Event or Problem · 0

    AN 8MM BARRICAID IMPLANTATION WAS PERFORMED. AFTER THE PROCEDURE WAS COMPLETED AND THE PATIENT'S SKIN INCISION WAS CLOSED, IT WAS NOTICED UPON REVIEW OF THE INTRA-OPERATIVE FLUOROSCOPIC IMAGES THAT THE NITINOL MESH GUIDE HAD FRACTURED AND SEPARATED FROM THE PUSHER DURING IMPLANTATION. AS THIS WAS NOT NOTICED DURING THE PROCEDURE, THE FRACTURED MESH GUIDE STILL RESIDED IN THE POLYMER BARRIER OF THE IMPLANT IN THE PATIENT. ON (B)(6) 2022, A REOPERATION WAS PERFORMED TO REMOVE THE FRACTURED MESH GUIDE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959038 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 04302117 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention