BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 20795291 · Received November 26, 2024

    Report

    Report Number
    MW5162912
    Event Type
    Other
    Date Received
    November 26, 2024
    Date of Event
    November 13, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY FIELD CLINICAL SPECIALIST, AFTER THE VALVE DEPLOYED AND THE ESHEATH+ REMOVED, THE PROGLIDE WAS DEPLOYED. THAT CAUSED DISSECTION AT THE ACCESS SITE. NOTHING WAS RELATED TO (B)(6) DEVICE. 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
    2359653 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown