BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

    MDR report key: 20098837 · Received August 28, 2024

    Report

    Report Number
    MW5159024
    Event Type
    Other
    Date Received
    August 28, 2024
    Date of Event
    August 20, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AT THE END OF A TRANSFEMORAL TAVRCASE FLOW WAS NOTED TO BE "SLUGGISH" AND THERE WAS A SMALL AREA OF EXTRAVASATION NOTED WHEN LOOKING AT THE ANGIOGRAM FOR ACCESS. THE TEAM STATED THAT THE PER-CLOSE DEVICE WAS UNABLE TO BE DEPLOYED DUE TO THE PATIENT'S HEAVILY CALCIFIED ACCESS AREA. DISCLAIMER STATEMENT: 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
    1244851 PERCLOSE VASCULAR SUTURE DELIVERY DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown