BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MO.MA. ULTRA 6F ID

    MDR report key: 3123483 · Received May 22, 2013

    Report

    Report Number
    3004066202-2013-00083
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 19, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULT: (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED). CONCLUSION: UNABLE TO CONFIRM COMPLAINT ( NO DEVICE RETURNED). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: COMPONENT/SUBASSEMBLY FAILURE (HUB LEAKAGE). EVALUATION CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A MOMA DEVICE IN A ICA STENOSIS; AFTER THE PREPARATION WHEN THE ECA BALLOON WAS INFLATED IT WAS NOTED THAT THE BALLOON WAS DEFLATING. THE PHYSICIAN REMOVED THE DEVICE AND HE USED ANOTHER ONE SUCCESSFULLY. THE DEVICE WAS THE FIRST USED TO TREAT THE LESION. NO ABNORMALITIES WERE NOTED DURING INSPECTION AND PREP PRIOR TO USE. THE BALLOON PROPERLY INFLATED BUT IT DEFLATED SPONTANEOUSLY AFTER ABOUT 60-90 SEC. NO INJURY WAS CAUSED TO THE PATIENT.

    Description of Event or Problem · 1

    DEVICE EVALUATION THE DEVICE, STOPCOCKS AND HAEMOSTATIC VALVE WERE RETURNED FOR EVALUATION. THE LUMENS WERE OCCLUDED BY DRIED RADIO OPAQUE SOLUTION SO TO INFLATE THE BALLOONS THE INFLATION LINES WERE CUT AND NEEDLES WERE BONDED IN IT. BOTH BALLOON WERE TESTED BY INFLATING THEM. NO LEAKAGE WAS DETECTED AFTER 15 MINUTES OF INFLATION IN EITHER BALLOON. THE INFLATION LINES WERE TESTED AND A LEAK WAS DETECTED IN THE ECA LINE. NO LEAK WAS FOUND IN THE CCA LINE. THE UPPER SEMI-SHELL OF THE HUB WAS REMOVED AND PRESSURE WAS APPLIED TO THE ECA INFLATION LINE USING THE VACLOK FILLED BY RED WATER. A TINY TRACES OF THE RED LIQUID USED FOR BALLOON INFLATION WAS NOTICED OVER THE LUER BONDING ZONE OF THE DISTAL LINE. BY USING AGAIN THE VACLOK SYRINGE CONNECTED TO THE LUER PORT, NEGATIVE PRESSURE WAS APPLIED: THE RED LIQUID RE-CROSSED THE DISTAL LUER BONDING ZONE AND THEN BUBBLES ROSE FROM THE INFLATION LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225979 MO.MA. ULTRA 6F ID CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA 1D033998

    Patients

    Seq Age Sex Outcome Treatment
    1