BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 PRO

    MDR report key: 3770515 · Received January 21, 2014

    Report

    Report Number
    2242352-2014-00006
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 27, 2013
    Report Date
    December 30, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K091733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF THE BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES. THE BTT BALLOON WAS INFLATED WITH 25 CC OF AIR THROUGH THE BALLOON INFLATION PORT AND SUBMERGED IN WATER; NO LEAKAGE WERE OBSERVED. THE CO2 INSUFFLATION POT WAS TESTED; AIR WOULD NOT FLOW THROUGH. ADHESIVE WAS OBSERVED IN THE INSUFFLATION OPENING ON THE BODY. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. ADDITIONAL EVALUATION WILL BE NEEDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE COMPLETE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BTT SHORT PORT ON THE VASOVIEW 6 PRO DID NOT ALLOW CO2 TO FLOW THROUGH THE PORT. AN ACCESSORY PACK WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51275 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC VH-2400 25088429

    Patients

    Seq Age Sex Outcome Treatment
    1 NI