BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 6 EVH SYSTEM

    MDR report key: 2162021 · Received July 11, 2011

    Report

    Report Number
    2242352-2011-00904
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DISSECTION TIP NOSE HAD DETACHED FROM THE JUICER. THE COMPONENTS FORMED A COMPLETE ASSEMBLY. THERE WAS SOME EVIDENCE OF ADHESIVE ALONG THE JOINTS. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "NOSE TIP BROKE" WAS CONFIRMED. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 6 DISSECTION NOSE TIP DETACHED AND HAD TO BE RETRIEVED OUT OF THE LEG THROUGH THE ORIGINAL INCISION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 6 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other