BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI 17

    MDR report key: 16618079 · Received March 27, 2023

    Report

    Report Number
    3015531723-2023-00005
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    March 10, 2023
    Report Date
    March 27, 2023
    Manufacturer
    RAPID MEDICAL LTD.
    Product Code
    PUU
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COMANECI 17 WAS DEPLOYED ACROSS THE NECK OF THE BASILAR ANEURYSM. 5 TARGET COILS WERE DETACHED. UPON DETACHMENT OF THE FINAL COIL, IT WAS DISCOVERED A COIL WAS ENTANGLED WITHIN THE MESH OF THE COMANECI 17. THE PHYSICIAN REDUCED AND EXPANDED COMANECI 17 BUT WAS UNABLE TO SEPARATE THE COIL FROM THE COMANECI 17. THE PHYSICIAN ULTIMATELY ADVANCED HIS BENCHMARK TO THE COMANECI 17 AND PULLED IT ALONG WITH THE COIL OUT OF THE BODY. A LOOP OF ANOTHER COIL WAS THEN IN THE PCA AND BASILAR. THE PHYSICIAN DEPLOYED TWO ATLAS STENTS TO TACK DOWN THE COIL LOOPS AND THEN THE PROCEDURE ENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933894 COMANECI 17 COMANECI 17 PUU RAPID MEDICAL LTD. ANPP7199

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention