BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISSECTION TIP

    MDR report key: 1232152 · Received November 14, 2008

    Report

    Report Number
    2953148-2008-00916
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 4, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K020143
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT AND THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, STAFF OBSERVED BLOOD LEAKING INSIDE THE CONICAL DISSECTION TIP EVEN THOUGH THEY HAD TAKEN PRECAUTIONS TO ENSURE THE TIP HAD BEEN SECURELY ATTACHED. THE PROCEDURE WAS CONVERTED TO A BRIDGING TECHNIQUE. THE PROCEDURE WAS CONVERTED BECAUSE THE HOSPITAL DID NOT FEEL COMFORTABLE OPENING ANOTHER KIT AND THEY DID NOT HAVE ANY ACCESSORY KIT WITH THE DISSECTION CONICAL TIP AVAILABLE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS AFTER THE PROCEDURE. THE HOSPITAL STATED THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISSECTION TIP GEI GUIDANT CARDIAC SURGERY VH-1114 8081873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention