BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2191172 · Received July 29, 2011

    Report

    Report Number
    2242352-2011-01028
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION: VISUAL INSPECTION REVEALED THAT THE SEAL WAS RETURNED W/O THE LOADING DEVICE AND THE DELIVERY DEVICE. THE TENSION SPRING ASSEMBLY WAS REC'D SEPARATE WITH THE BLUE STRING CUT. THE SEAL WAS COMPLETELY UNRAVELED AND BLOODY. BASED UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL DID NOT PROVIDE SUFFICIENT HEMOSTASIS" COULD NOT BE CONFIRMED. IT IS NOT POSSIBLE TO CONFIRM OR DENY THE COMPLAINT AS THE SEAL WAS REC'D COMPLETELY UNRAVELED SO NO FURTHER TESTING COULD BE DONE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL DID NOT PROVIDE SUFFICIENT HEMOSTASIS. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY FURTHER PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25018646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other