BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MO.MA. ULTRA 6F ID

    MDR report key: 3131627 · Received May 29, 2013

    Report

    Report Number
    3004066202-2013-00085
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: DEVICE RETURNED (EVALUATION IN PROGRESS). EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT (EVALUATION IN PROGRESS). INCONCLUSIVE-EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: USER/DEVICE INTERFACE - THE POSSIBILITY EXISTS THAT THE EXIT PORT OF THE WORKING CHANNEL WAS VERY CLOSE TO THE COMMON CAROTID ARTERY WALL, AND DURING THE ASPIRATION ATTEMPT A VACUUM WAS CREATED RESULTING IN THE DEVICE BECOMING TOTALLY ADHERED TO THE VESSEL WALL. INCORRECT TECHNIQUE/PROCEDURE-THE POSSIBILITY EXISTS THAT THE EXIT PORT OF THE WORKING CHANNEL WAS VERY CLOSE TO THE COMMON CAROTID ARTERY WALL, AND DURING THE ASPIRATION ATTEMPT A VACUUM WAS CREATED RESULTING IN THE DEVICE BECOMING TOTALLY ADHERED TO THE VESSEL WALL. EVALUATION CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT-THE POSSIBILITY EXISTS THAT THE EXIT PORT OF THE WORKING CHANNEL WAS VERY CLOSE TO THE COMMON CAROTID ARTERY WALL, AND DURING THE ASPIRATION ATTEMPT A VACUUM WAS CREATED RESULTING IN THE DEVICE BECOMING TOTALLY ADHERED TO THE VESSEL WALL. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE FIELD REPORTED THAT THE PHYSICIAN COMMENTED THAT IT IS POSSIBLE THE EVENT MAY HAVE BEEN CAUSED BY VESSEL ANATOMY OR KINK OF THE DEVICE. EVALUATION SUMMARY: BOTH THE CATHETER AND THE HOLLOW MANDREL WERE RETURNED. THE WORKING CHANNEL ACCESSORIES (HEMOSTATIC VALVE, EXTENSION LINE AND 3-WAY STOPCOCK) WERE SCREWED TO THE CENTRAL LUER PORT. BOTH THE 1-WAY STOPCOCKS WERE SCREWED TO THE LATERAL LUER PORTS. MOREOVER, TO THE DISTAL BALLOON INFLATION PORT, ALSO A 2.5ML SYRINGE FILLED WITH ABOUT 1ML OF SOLUTION WAS CONNECTED. THE DISTAL BALLOON WAS INFLATED.VISUAL INSPECTION DID NOT HIGHLIGHT ANY DEFECT TO THE CATHETER OR THE HOLLOW MANDREL. TO VERIFY THE STATUS OF THE WORKING CHANNEL LUER, TESTING WAS CARRIED OUT. THE HOLLOW MANDREL WAS INSERTED THROUGH THE HEMOSTATIC VALVE INSIDE THE DEVICE WORKING CHANNEL TO THE EXIT PORT WITH NO FRICTION OBSERVED. WATER ASPIRATION HAS BEEN VERIFIED WITH A 30ML SYRINGE DIRECTLY SCREWED TO THE WORKING CHANNEL LUER PORT AS WELL TO THE SIDE PORT OF THE 3-WAY STOPCOCK WITH NO ISSUE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION WITH A MO MA ULTRA DEVICE. THE PROCEDURE WAS PERFORMED ACCORDING TO IFU. AFTER ECA BALLOON WAS INFLATED CCA BALLOON WAS INFLATED TO INTERRUPT BLOOD FLOW. THEN THE PHYSICIAN ATTEMPTED TO PERFORM ASPIRATION, BUT IT WAS FAILED. THE PHYSICIAN RE-TRIED ASPIRATION MANY TIMES WITH REPOSITION OF THE OCCLUSION BALLOONS, BUT ASPIRATION FAILURE WAS NOT ABLE TO BE RESOLVED. THE PHYSICIAN STOPPED THE USE AND COMPLETED THE OPERATION PROCEDURE WITH ANOTHER MOMA. NO HEALTH HAZARD TO THE PATIENT. THERE WERE NO ABNORMALITIES DURING THE NEGATIVE PREP BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236144 MO.MA. ULTRA 6F ID CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA 1D038889

    Patients

    Seq Age Sex Outcome Treatment
    1