BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1934324 · Received November 24, 2010

    Report

    Report Number
    2242352-2010-03451
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE DISSECTION TIP WAS RECEIVED AS A COMPLETE ASSEMBLY. THERE WAS SOME BLOOD ALONG THE CONNECTION OF THE TWO TIP COMPONENTS. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "FOGGY" WAS CONFIRMED SINCE THERE WAS BLOOD IN THE TIP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS OBSERVED THAT THE DISSECTION CONE DEVELOPED CONDENSATION INSIDE THE TIP OF THE CONE AND REMAINED "FOGGY." A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25021213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA