BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1924643 · Received December 7, 2010

    Report

    Report Number
    2242352-2010-03534
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: UPON RECEIPT OF THE PRODUCT ON DECEMBER 06, 2010, IT WAS OBSERVED THAT THE RETURNED PRODUCT WAS NOT CONSISTENT WITH THE REPORTED EVENT. WE WILL CONTINUE TO FOLLOW UP WITH THE REPORTER TO RECEIVE ADDITIONAL INFORMATION. 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 "THE TIP OF THE DISSECTION CONE FELL OFF" WAS NOT 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, DURING TISSUE DISSECTION THE TIP OF THE DISSECTION CONE FELL OFF INTO THE PATIENT. IT WAS VISUALIZED AND REMOVED THRU THE SAME INCISION. AN ACCESSORY KIT WAS OPENED AND ANOTHER TIP WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT OR HARM TO THE PATIENT.

    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 25021543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other