BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2080194 · Received April 7, 2011

    Report

    Report Number
    2242352-2011-00252
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 9, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, FOUR HEARTSTRING III SEALS FAILED TO LOAD. THE SEALS STAYED IN THE LOADING DEVICES AND DID NOT ROLL PROPERLY. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 4.3MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HSK-3043 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA