BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI

    MDR report key: 10261766 · Received July 11, 2020

    Report

    Report Number
    3009957947-2020-00004
    Event Type
    Injury
    Date Received
    July 11, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 11, 2020
    Manufacturer
    RAPID MEDICAL LTD
    Product Code
    PUU
    PMA / PMN Number
    DEN 170064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OFF LABEL USE.

    Description of Event or Problem · 1

    ON JUNE 11, 2020, RAPID MEDICAL OBTAINED INFORMATION ABOUT A PROCEDURE TO COIL A BRAIN ANEURYSM WHERE A COMANECI WAS USED OFF-LABEL. WE WERE INFORMED THAT A COMANECI DEVICE WAS USED IN AN ATTEMPT TO RECOVER A STENT RETRIEVER AND COIL MASS THAT HAD BECOME ENTANGLED. THE INFORMATION INDICATES THAT DURING A COILING PROCEDURE OF A CAROTID ANEURYSM, THE SURGEON ATTEMPTED TO USE A STENT RETRIEVER AS A SNARE TO CAPTURE A COIL LOOP THAT HAD ESCAPED FROM THE ANEURYSM, AND WHEN THAT WAS UNSUCCESSFUL THE SURGEON ATTEMPTED TO USE A COMANECI AS A SNARE TO CAPTURE THE STENT RETRIEVER AND COIL MASS. IN THE PROCESS, THE COMANECI BECAME ENTANGLED WITH THE COIL AND STENT RECEIVER, WHICH EVENTUALLY RESULTED IN A MIGRATION TO THE CAROTID TERMINUS WHERE THEY REMAINED. WE UNDERSTAND THAT A PORTION OF THE COMANECI DEVICE WAS RECOVERED, AND WE ARE WORKING DILIGENTLY TO OBTAIN THAT SEGMENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725858 COMANECI COMANECI PUU RAPID MEDICAL LTD ANPP3177 190218CC01

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability