BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1982764 · Received January 6, 2011

    Report

    Report Number
    2242352-2010-03880
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE DISSECTION TIP WAS RECEIVED WITH THE CONICAL TIP ATTACHED, BUT IT COULD BE REMOVED WITH MINIMAL FORCE. THE TIP FORMED A COMPLETE ASSEMBLY. THERE WAS SOME ADHESIVE VISIBLE ON THE CONNECTING SURFACES. THERE WAS SOME EVIDENCE OF BLOOD IN THE TIP. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "DISSECTION TIP SEPARATED" WAS CONFIRMED. 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, THE DISSECTION TIP SEPARATED FROM THE MAIN PART DURING SET-UP FOR THE PROCEDURE. 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 7 XB EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25003582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA