BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDWIRE TEMPORARY OCCLUSION SYSTEM

    MDR report key: 8008421 · Received October 26, 2018

    Report

    Report Number
    1220452-2018-00126
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    August 22, 2018
    Report Date
    October 26, 2018
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K023878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIT REF: HTTPS://DOI.ORG/10.1007/S00234-018-2085-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM THE LITERATURE ARTICLE: A TRANSBRACHIAL CAS TECHNIQUE WITH PROXIMAL PROTECTION BY SHEATHLESS NAVIGATION OF A 9-F BALLOON-GUIDING CATHETER WITH AN OUTER DIAMETER EQUIVALENT TO A 7-F SHEATH WAS PERFORMED IN 8 CONSECUTIVE PATIENTS AMONG 39 PATIENTS WHO UNDERWENT CAS FROM APRIL 2016 TO JUNE 2017. MEDTRONIC DEVICES SUCH AS CAROTID GUARDWIRE AND SPIDER FX WERE USED DURING THE PROCEDURE. TECHNICAL SUCCESS WAS ACCOMPLISHED IN ALL PATIENTS. ONE PATIENT EXPERIENCED A THROMBOEMBOLIC EVENT, ALTHOUGH NO NEW NEUROLOGICAL DEFICITS WERE OBSERVED. A PSEUDOANEURYSM AT THE ACCESS SITE, WHICH REQUIRED ULTRASOUND-GUIDED COMPRESSION, OCCURRED IN ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850254 GUARDWIRE TEMPORARY OCCLUSION SYSTEM CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention