BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F (2.0MM)

    MDR report key: 17939957 · Received October 13, 2023

    Report

    Report Number
    MW5146959
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    September 29, 2023
    Report Date
    October 11, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ABBOTT VASCULAR PERCLOSE PROGLIDE MISFIRED. THE SUTURE GOT CAUGHT IN THE DEVICE AND WOULD NOT COME OFF THE DEVICE. WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE VESSEL, IT TORE A LARGER HOLE IN THE VESSEL REQUIRING A REPAIR OF THE RIGHT FEMORAL ARTERY. A SECOND ABBOTT VASCULAR PERCLOSE PROGLIDE FELL APART AT THE HANDLE WHEN REMOVED FROM THE PACKAGE NEVER REACHED THE PATIENT. WE HAVE THE LOT NUMBERS OF BOTH DEVICES BUT ARE UNABLE TO IDENTIFY WHICH WAS USED ON THE PATIENT. THE PT WAS OBESE, THE VESSEL WAS DEEP AND TORTUOUS. (17) 241031 (10) 2120341 (91) 3798, CANNOT CONFIRM THIS WAS THE DEVICE THAT MISFIRED, THERE WERE ISSUES WITH 2 DEVICES. REFERENCE REPORT: MW5146958.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312094 PERCLOSE PROGLIDE 6F (2.0MM) DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention