BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING II PROXIMAL SEAL SYSTEM

    MDR report key: 1349170 · Received December 22, 2008

    Report

    Report Number
    2953148-2008-01011
    Event Type
    Malfunction
    Date Received
    December 22, 2008
    Report Date
    November 12, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED.

    Description of Event or Problem · 1

    MAQUET CARDIOVASCULAR RECEIVED A PER ON 11/12/2008 FROM OUR INTERNATIONAL AFFILIATE STATING, "THE LOADING OF THREE SEALS INTO THE DELIVERY DEVICE WAS NOT POSSIBLE. THESE PRODUCTS COULD NOT BE USED. THE SURGEON USED A REPLACEMENT HEARTSTRING SEAL TO COMPLETE THE PROCEDURE." ADDITIONAL INFORMATION WAS PROVIDED TO MAQUET CARDIOVASCULAR ON 12/03/2008 STATING, "THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, THREE HEARTSTRING SEALS UNRAVELED WHILE LOADING THE SEALS INTO THE DELIVERY TUBE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL." BASED ON THIS ADDITIONAL INFORMATION PROVIDED ON 12/03/2008, IT WAS DETERMINED THAT THIS IS AN MDR REPORTABLE EVENT. THIS REPORT IS FOR THE FIRST SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING II PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-1045 8051471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA