BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE

    MDR report key: 17278982 · Received July 6, 2023

    Report

    Report Number
    MW5119169
    Event Type
    Other
    Date Received
    July 6, 2023
    Date of Event
    June 21, 2023
    Report Date
    June 30, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MULTIPLE PERCLOSE FAILURE COMPLICATIONS ALONG WITH HEAVILY CALCIFIED VASCULATURE LED TO BLEEDING IN THE PATIENT¿S RIGHT CFA REQUIRING A SURGICAL CUT DOWN AND REPAIR. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497274 PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown