BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2315151 · Received October 13, 2011

    Report

    Report Number
    2242352-2011-01526
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 10, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DQD
    PMA / PMN Number
    K050169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THREE HEARTSTRING III MALFUNCTIONED. THE FIRST DID NOT FIRE, THE SECOND DID NOT DEPLOY AND THE THIRD DID NOT REMAIN IN THE AORTA AFTER BEING FIRED. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES THE RETURN OF THE PRODUCT IN QUESTION. REFER TO 2242352-2011-01525 AND 2242352-2011-01527.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 4.3MM CLAMPLESS BEATING HEART DQD MAQUET CARDIOVASCULAR, LLC HSK-3043 25038635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA