BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI 17

    MDR report key: 16618081 · Received March 27, 2023

    Report

    Report Number
    3015531723-2023-00006
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    December 14, 2022
    Report Date
    March 27, 2023
    Manufacturer
    RAPID MEDICAL LTD.
    Product Code
    PUU
    UDI-DI
    07290015107150
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THROMBUS FORMATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF COIL EMBOLIZATION ASSIST DEVICES, INCLUDING COMANECI DEVICE. THE IFU IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. A 58-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, HYPONATREMIA, TOBACCO ABUSE DISORDER, AND PREVIOUS ANEURYSMS, WAS TREATED WITH THE COMANECI 17 (L-MCA ANEURYSM). SUBJECT TOLERATED THE PROCEDURE BUT SHORTLY AFTER DEVELOPED RIGHT SIDED WEAKNESS, NEGLECT, INCOMPREHENSIBLE SPEECH (NIHSS 20). CT HEAD W/O CONTRAST NEGATIVE FOR ACUTE INTRACRANIAL ABNORMALITIES. SUBJECT WAS TAKEN BACK TO THE IR SUITE FOR A CEREBRAL ANGIOGRAM WHICH DEMONSTRATED DISTAL OCCLUSIONS, AGRRASTAT WAS INJECTED. S/P INJECTION PATIENT ABLE TO MOVE RIGHT SIDE, ALERT AND ORIENTED TO PERSON, ABLE TO SPEAK AND ANSWER QUESTIONS WITH SOME APHASIA AND DYSARTHRIA NOTED, SHE HAS FACIAL DROOP (NIHSS 8).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934569 COMANECI 17 COMANECI 17 PUU RAPID MEDICAL LTD. ANPP7199 220917CS01 07290015107150

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Disability