BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMANECI PETIT

    MDR report key: 10128360 · Received June 8, 2020

    Report

    Report Number
    3009957947-2020-00003
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 8, 2020
    Manufacturer
    RAPID-MEDICAL LTD
    Product Code
    PUU
    UDI-DI
    07290015107044
    PMA / PMN Number
    DEN170064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OFF-LABEL USE: IN THIS EVENT THE COMANECI WAS USED TO POST DILATE A STENT. STENT POST DILATION IS NOT PART OF THE COMANECI INTENDED USE. PER THE INSTRUCTION FOR USE (IFU): THE COMANECI EMBOLIZATION ASSIST DEVICE IS INDICATED FOR USE IN THE NEUROVASCULATURE AS A TEMPORARY ENDOVASCULAR DEVICE USED TO ASSIST IN THE COIL EMBOLIZATION OF WIDE-NECKED INTRACRANIAL ANEURYSMS WITH A NECK WIDTH 10 MM. A WIDE-NECKED INTRACRANIAL ANEURYSM DEFINES THE NECK WIDTH AS 4 MM OR A DOME-TO-NECK RATIO < 2.

    Description of Event or Problem · 1

    RAPID MEDICAL WAS NOTIFIED THAT DURING ENDOVASCULAR TREATMENT WITH ATLAS STENT OF SEVERE VASOSPASM THE STENT COULD NOT OPEN. THE PHYSICIAN DECIDED TO USE THE COMANECI DEVICE OUTSIDE OF ITS INTENDED USE TO POST DILATE THE STENT. AS A RESULT THE STENT DILATED SUCCESSFULLY, HOWEVER, THE COMANECI DEVICE GOT STUCK INSIDE THE STENT AND WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE PHYSICIAN THE PATIENT IMPROVED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592319 COMANECI PETIT COMANECI PETIT PUU RAPID-MEDICAL LTD ANPP3188 191101CP02 07290015107044

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability