BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2093427 · Received April 12, 2011

    Report

    Report Number
    2242352-2011-00268
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE ALSO RETURNED SEPARATE. THE UPPER CASING OF THE LOADING DEVICE HAD BEEN TAKEN APART AND THE SEAL HAD BEEN REMOVED. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL WOULD NOT LOAD PROPERLY" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THIS REPORTED PRODUCT LOT NUMBER. THERE WAS NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL WOULD NOT LOAD PROPERLY. THIS OCCURRED 4 TIMES. A REPLACEMENT UNIT WAS USED TO COMPETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS . ONLY 2 OUT OF THE 4 UNITS ARE RETURNING. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25009901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA