BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1052943 · Received May 27, 2008

    Report

    Report Number
    2953148-2008-00568
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 6, 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
    JA
    Reporter Occupation
    PHYSICIAN

    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

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, ONE HEARTSTRING SEAL DID NOT DEPLOY WHEN THE DOCTOR PUSHED THE PLUNGER. THE DOCTOR FELT THE DEPLOYMENT TUBE BEGINNING TO SEPARATE FROM THE HUB WHEN IT FAILED TO DEPLOY, SO HE HELD THE DEVICE IN SUCH A WAY THAT THE TUBE DID NOT SEPARATE & REMAIN IN THE AORTA BUT RATHER SEPARATED AFTER HE REMOVED THE HEARTSTRING DEVICE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-1045 7111471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA