BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1051439 · Received May 21, 2008

    Report

    Report Number
    2953148-2008-00552
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 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
    TX, US
    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. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL INITIALLY REPORTED FOR INCIDENT (B) (4) THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY FOR THREE PROXIMAL ANASTOMOSIS, SEVEN HEARTSTRING SEALS CRACKED WHILE LOADING THE SEALS INTO THE DELIVERY TUBE. DURING THE SAME PROCEDURE, TWO HEARTSTRING SEALS DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. SEALS NUMBERED 5 THROUGH 9 WERE USED BEYOND THE EXPIRATION DATE OF FEB 29, 2008. A MEDWATCH REPORT WAS RECEIVED BY THIS HOSPITAL ON 05/14/08 AND INCLUDED TWO MORE HEARTSTRING SEALS CRACKED WHILE LOADING THE SEALS INTO THE DELIVERY TUBE DURING THE SAME CASE DESCRIBED IN (B) (4). THE ADDITIONAL TWO SEALS WERE CAPTURED (B) (4). THE MEDWATCH REPORT STATED, "THE SURGEON ABANDONED USE OF THE MEDICAL DEVICES AND USED ANOTHER TECHNIQUE. PT EXPERIENCED TEMPORARY HYPOVOLEMIA RELATED TO BLOOD LOSS". MAQUET MADE MULTIPLE ATTEMPTS TO CONTACT THE ATTENDING SURGEON AND THE CVOR COORDINATOR/NURSE WHO INITIALLY REPORTED THE INCIDENT AND WAS IN OR DURING THE CASE. THE CVOR COORDINATOR/NURSE CONFIRMED ON 05/20/08, "THE PROCEDURE WAS COMPLETE USING A REPLACEMENT SEAL. THE PT DID LOSE APPROXIMATELY 6 UNITS OF BLOOD; HOWEVER, NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL AND THE PT IS CURRENTLY DOING FINE." THE LAST SEAL NOTED IN (B) (4) WILL IDENTIFY PT CODE FOR BLOOD LOSS. THIS REPORT IS FOR THE NINTH SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-1045 7032182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA