BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3001912 · Received February 12, 2013

    Report

    Report Number
    2242352-2013-00074
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, RESISTANCE WAS FELT WHILE REMOVING THE HEARTSTRING III SEAL FROM THE AORTOTOMY AS THE SEAL DID NOT FULLY UNRAVEL AT THE CENTER. THE SURGEON STATED THAT THERE WAS NO DAMAGE TO THE AORTA. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61358 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25062641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA