BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT PERCLOSE HEMOSTATIS DEVICE

    MDR report key: 17534778 · Received August 12, 2023

    Report

    Report Number
    MW5141678
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    January 1, 2022
    Report Date
    February 17, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF THIS ADVERSE EVENT AS THE SUSPECTED DEVICE OF THE ABBOTT PERCLOSE (HEMOSTATIS DEVICE) IS NOT MANUFACTURED OR IMPORTED BY BIOSENSE WEBSTER, INC. IT WAS REPORTED PERCLOSE (HEMOSTASIS DEVICE) WAS USED AND HEMOSTASIS WAS CONDUCTED. VENOUS STENOSIS AND THROMBUS AT THE HEMOSTATIC SITE WERE CONFIRMED AFTER THE PROCEDURE, WHICH WAS RESOLVED BY SURGICAL OPERATION. THIS EVENT OCCURRED AFTER THE PROCEDURE. STENOSIS WAS RESOLVED BY SURGICAL OPERATION AND THE THROMBUS WAS REMOVED. VENOUS STENOSIS, AND THROMBUS AT THE HEMOSTATIC SITE. PERCLOSE WAS USED AND HEMOSTASIS WAS CONDUCTED, AND THE KNOT ENTERED INSIDE THE BLOOD VESSEL, RESULTING IN STENOSIS AND THROMBOSIS. THE EVENT WAS RESOLVED BY SURGICAL OPERATION, AND THE PATIENT'S CONDITION IMPROVED. THE PHYSICIAN COMMENTED THAT NO CAUSAL RELATIONSHIP WITH BWI COMPANY PRODUCT, DUE TO PERCLOSE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049700 ABBOTT PERCLOSE HEMOSTATIS DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown