BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SYTEM 3.8 MM

    MDR report key: 3843232 · Received March 14, 2014

    Report

    Report Number
    2242352-2014-00255
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE SAFETY LOCK WAS UNLOCKED AND THE ACTUATION BUTTON WAS DEPRESSED. THE OUTSIDE CASING WAS SLIGHTLY SEPARATED. ADDITIONAL EVAL IS REQUIRED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AORTIC CUTTER ON THREE HEARTSTRING II MADE A PROPER AORTOTOMY, BUT THE CASING CRACKED WHEN THEY WERE FIRED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153478 HS III PROXIMAL SYTEM 3.8 MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25087037

    Patients

    Seq Age Sex Outcome Treatment
    1 NI