BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 2629167 · Received June 22, 2012

    Report

    Report Number
    2242352-2012-00628
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICES ARE RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBERS. THERE WERE NO NON-CONFORMANCES RECORDED IN THE LOT HISTORIES. (B)(4). ADD'L DEVICE INFO: BRAND NAME: HS III PROXIMAL SEAL SYTEM 3.8MM, COMMON DEVICE NAME: CLAMPLESS BEATING HEART, MANUFACTURE NAME: MAQUET CARDIOVASCULAR, LLC, (B)(4), MODEL#: HSK-3038, CATALOG: NA, SERIAL#: NA, LOT#: 25054563, EXP DATE: 3/31/2013, OTHER#: NA.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III SEALS DID NOT LOAD PROPERLY. THE FIRST SEAL ROLLED IMPROPERLY AND THE SEAL ON THE SECOND DEVICE STARTED TO ROLL AND THE EDGE BECAME CRIMPED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP INTENDS TO RETURN THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC. HSK-3038 25054723

    Patients

    Seq Age Sex Outcome Treatment
    1 NA