BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTRING II PROXIMAL SEAL SYSTEM

    MDR report key: 1132588 · Received August 22, 2008

    Report

    Report Number
    2953148-2008-00748
    Event Type
    Injury
    Date Received
    August 22, 2008
    Report Date
    June 30, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE HEARTSTRING DEPLOYMENT TUBE HAD SEPARATED FROM THE HUB. IT WAS ALSO OBSERVED THAT THE TENSION SPRING COMPONENTS AND THE SEAL WERE INSIDE THE DEPLOYMENT TUBE. A LOT HISTORY RECORD REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    MAQUET QA TECH OPENED THE RETURNED BOX FOR ANOTHER INCIDENT IN 2008, WHICH WAS SUPPOSED TO BE FOR A NON-MDR REPORTABLE EVENT ON A HEARTSTRING CUTTER; HOWEVER, THE CUSTOMER RETURNED A HEARTSTRING PROXIMAL SEAL INSTEAD. THE VISUAL INSPECTION SHOWED THAT THE SEAL WAS LOADED IN THE DEPLOYMENT TUBE AND CRACKED. OTHER OBSERVATIONS WERE THAT THE DEPLOYMENT TUBE SEPARATED FROM THE HUB. THE CUSTOMER DID NOT REPLY AFTER MULTIPLE ATTEMPTS TO GATHER FURTHER DETAILS ON THE PROD RETURN. THE FOLLOWING INFO IS UNK: PART NUMBER, LOT NUMBER, FAILURE DETAILS EXCEPT TUBE SEPARATED FROM HUB, HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS ANY PT EFFECT. THE EVENT WILL BE FILED AS A SERIOUS INJURY BECAUSE OF THE PT STATUS WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA