BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMPRO

    MDR report key: 3810953 · Received March 23, 2014

    Report

    Report Number
    2242352-2014-00326
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Report Date
    February 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. 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, THE BTT SHORT PORT WOULD NOT HOLD AIR ON THE VASO VIEW HEMOPRO. THERE WAS NO DELAY IN THE CASE AND AN ACCESSORY KIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171076 VASO VIEW HEMPRO ENDOSCOPIC VESSEL HARVESTING GEI BOSTON SCIENTIFIC CORPORATION VH-3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI