BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 ACCESSORY PACK

    MDR report key: 3383261 · Received September 5, 2013

    Report

    Report Number
    2242352-2013-00994
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 13, 2013
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE HEMOPRO 2 DEVICE, THE SHORT PORT BTT WOULD NOT ALLOW CO2 TO ENTER AND MAINTAIN THE RADIAL TUNNEL AFTER DISSECTION. THE INSUFFLATOR WAS CHECKED AND A REPLACEMENT SHORT PORT BTT WAS USED FROM AN EVH ACCESSORY KIT; HOWEVER, THE REPLACEMENT BTT WAS NOT SUCCESSFUL. THE PROCEDURE WAS CONVERTED AND THE FOREARM WAS OPENED TO HARVEST THE RADIAL ARTERY. REFER TO MFR REPORT # 2242352-2013-00912 FOR THE RELATED REPORT FOR THE FIRST DEVICE THAT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441751 VASOVIEW 6 ACCESSORY PACK ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-2004 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other