BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    MDR report key: 1994389 · Received January 14, 2011

    Report

    Report Number
    2242352-2010-03994
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A DEVICE LOT HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER. THERE WERE NO NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SEAL DID NOT COME OUT DURING USE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING PROXIMAL SEAL, 4.5 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HS-1045 25016206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA