BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3894564 · Received April 8, 2014

    Report

    Report Number
    2242352-2014-00390
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. 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 PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HS III PROXIMAL SEAL FAILED TO LOAD. THE LEAD TECH WAS CONFUSED WITH THE HEARTSTRING LOADING PROCESS. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. A MAQUET REPRESENTATIVE PERFORMED AN IN-SERVICE TRAINING AT THIS ACCOUNT ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212721 HS III PROXIMAL SEAL SYSTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI