BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTRING PROXIMAL SEAL SYSTEM

    MDR report key: 1940351 · Received December 20, 2010

    Report

    Report Number
    2242352-2010-04010
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    November 30, 2010
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THERE WAS NO RECORD OF THE EVENT HAVING BEEN COMMUNICATED TO A COMPANY REPRESENTATIVE AND NO RECORD OF THE EVENT IN COMPLAINTS DOCUMENTATION AROUND THE TIME THE EVENT REPORTEDLY TOOK PLACE. THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED FOR THE PRODUCT, AS THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    A MAQUET EMPLOYEE WAS MADE AWARE OF AN INCIDENT THAT TOOK PLACE AT (B)(6) HOSPITAL IN (B)(6) IN (B)(6) 2008. IT WAS STATED THAT THE ANCHOR TAB OF THE HEARTSTRING SEAL ASSEMBLY HAD DETACHED AND WAS LEFT IN THE PATIENT'S CHEST. THIS WAS DISCOVERED DURING A FOLLOW UP X-RAY. THE PT UNDERWENT A FOLLOW UP SURGERY AND THE PIECE WAS RETRIEVED AND THE PT RECOVERED WITH NO FURTHER PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING PROXIMAL SEAL SYSTEM HEARTSTRING PROXIMAL SEAL SYSTEM DXC MAQUET CARDIOVASCULAR, LLC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention