BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 PRO

    MDR report key: 3130197 · Received May 21, 2013

    Report

    Report Number
    2242352-2013-00514
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K091733
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE ARE RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS OBSERVED THAT TWO DISSECTION TIPS ON THREE VASOVIEW 6 PRO DEVICES WERE NOT VISIBLE ON THE MONITOR AS A WHITE POINT. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL INTENDS TO RETURN THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225402 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-2400 25070015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA