BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1940631 · Received December 22, 2010

    Report

    Report Number
    2242352-2010-03787
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 THIS OBSERVATION, THE REPORTED COMPLAINT "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. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP SEPARATED FROM THE MAIN PART IN THE PT. IT WAS RETRIEVED THROUGH THE ORIGINAL INCISION. 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 25020285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other