BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE

    MDR report key: 17488424 · Received August 9, 2023

    Report

    Report Number
    MW5121123
    Event Type
    Other
    Date Received
    August 9, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 22, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE EDWARDS COMMANDER DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A VASCULAR INJURY WAS OBSERVED. THE REPORTED CAUSE WAS DUE TO THE OPERATOR AND A NON-EW CLOSURE DEVICE FAILURE (PERCLOSE) THAT WASN'T SET CORRECTLY TEARING THE ARTERIOTOMY SITE. THERE IS NO ALLEGATION THAT THE EW DEVICE CAUSED OR CONTRIBUTED TO THE VASCULAR INJURY. EW REFERENCE NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 22-AUG-2023 FOR MW5121123. CORRECTING PROCODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483501 PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR
    1904493 PERCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown