BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3261439 · Received July 30, 2013

    Report

    Report Number
    2242352-2013-00731
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR
    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. INTERNAL FILE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, A CRACK WAS FOUND ON THE HEARTSTRING III SEAL LOCATED ON THE SECOND ROW FROM THE CENTER. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355977 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR HS-3045 25068871

    Patients

    Seq Age Sex Outcome Treatment
    1 NI