BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI

    MDR report key: 12337259 · Received August 18, 2021

    Report

    Report Number
    3009957947-2021-00006
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 18, 2021
    Manufacturer
    RAPID-MEDICAL LTD
    Product Code
    PUU
    UDI-DI
    07290015107150
    PMA / PMN Number
    DEN170064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. COIL PROTRUSION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF COIL EMBOLIZATION ASSIST DEVICES, INCLUDING COMANECI. HOWEVER, ACCORDING TO PHYSICIAN REPORT, IT IS POSSIBLE THAT THE PROTRUDING OF THE SUBJECT DEVICE INTO THE ANEURYSM, AS IT WAS BEING WITHDRAWN, MAY HAVE BEEN ASSOCIATED TO THE PATIENT'S CHALLENGING ACUTE BASILAR-PCA ANGLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A WIDE-NECKED BASILAR TIP ANEURYSM, THE COMANECI 17 WAS PROTRUDED INTO THE ANEURYSM COIL MASS AS IT WAS BEING WITHDRAWN. AFTER MULTIPLE MANIPULATIONS THE PHYSICIAN WITHDREW THE DEVICE AND COMPLETED THE ANEURYSM COILING PROCEDURE, HOWEVER ONE COIL REMAINED HERNIATED INTO THE PARENT ARTERY. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL CONSEQUENCE. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232438 COMANECI COMANECI 17 PUU RAPID-MEDICAL LTD ANPP7199 210304CS01 07290015107150

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability