BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI

    MDR report key: 16384861 · Received February 16, 2023

    Report

    Report Number
    3009957947-2023-00003
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 16, 2023
    Manufacturer
    RAPID-MEDICAL LTD.
    Product Code
    PUU
    PMA / PMN Number
    DEN170064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE. COIL ENTANGLEMENT IS A POTENTIAL, BUT RARE COMPLICATION ASSOCIATED WITH THE USE OF THE COMANECI DEVICE. THE LABELING INCLUDES RECOMMENDATION TO VERIFY THE COIL'S STABILITY IN THE ANEURYSM BY DEFLATING THE DEVICE BEFORE COIL DETACHMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMANECI WAS USED AS COIL ASSIST DEVICE TO TREAT LARGE RUPTURE PCOM ANEURYSM. AFTER 3 COILS HAD BEEN DEPLOYED AND DETACHED , COMANECI WAS ATTEMPTED TO BE RETRIEVED, HOWEVER ONE LOOP WAS HOOKED IN THE COMANECI MESH, AND ANOTHER COIL WAS PROTRUDING AND STRETCHED FROM COLI MASS ALL OF THE WAY DOWN INTO THE GROIN. SEVERAL MANEUVERS WERE MADE WITH SNARE AND SOLITAIRE DEVICE TO REMOVE THE STRETCHED COIL FROM THE PATIENT, EVENTUALLY, THE COIL WAS MOSTLY REMOVED. THE PROCEDURE WAS COMPLETED BY IMPLEMENTING ADDITIONAL COIL, THE ANEURYSM WAS PACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354808 COMANECI COMANECI PUU RAPID-MEDICAL LTD. ANPP7177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention