BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8 MM

    MDR report key: 4102557 · Received August 27, 2014

    Report

    Report Number
    2242352-2014-00934
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMITY RECORDED IN THE LOG HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING II UNRAVELED. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519003 HS III PROXIMAL SEAL SYSTEM 3.8 MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR LLC HSK-3038 25098596

    Patients

    Seq Age Sex Outcome Treatment
    1