BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRION

    MDR report key: 7804299 · Received August 22, 2018

    Report

    Report Number
    3012121095-2018-00001
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 26, 2018
    Report Date
    August 22, 2018
    Manufacturer
    GARDIA MEDICAL LTD.
    Product Code
    NTE
    UDI-DI
    07290015512015
    PMA / PMN Number
    K143570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CAROTID PROCEDURE WAS CONDUCTED ON A (B)(6) YEAR OLD MALE. THE FILTER WAS SUCCESSFULLY PLACED IN THE INTERNAL CAROTID ARTERY WITH NO ISSUES. THE CAROTID PROCEDURE WAS COMPLETED WITH NO EVENTS. ONCE TRYING TO RETRIEVE THE FILTER, IT WOULD NOT COLLAPSE. NO VISIBLE OBSTRUCTION OR TORTUOUS ANATOMY WAS OBSERVED. THE PHYSICIAN APPLIED HIGH FORCE IN ORDER TO RETRIEVE THE FILTER. EVENTUALLY IT WAS RETRIEVED AND IT WAS NOTED THAT THE TIP OF THE FILTER WAS MISSING AND IT WAS LOCATED LODGED IN THE DISTAL ICA. THE TIP WAS CAPTURED AND RETRIEVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647918 WIRION WIRION EPD NTE GARDIA MEDICAL LTD. P2-9-0705-S DS17003 07290015512015

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention