BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 2881448 · Received December 17, 2012

    Report

    Report Number
    2522007-2012-00029
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K010055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFORMATION SUPPLIED TO TRACKWISE, THIS PRODUCT IS NOT BEING RETURNED FOR EVALUATION. "AS THE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED."

    Description of Event or Problem · 1

    COOK MEDICAL REPORTED FOR THE CUSTOMER, "DURING THE COURSE OF A LEAD EXTRACTION, UTILIZING THE EVOLUTION, BLOOD PRESSURE DROPPED EXCESSIVELY. THE PROCEDURE WAS STOPPED AT THIS TIME. A CARDIOVASCULAR SURGEON WAS BROUGHT IN. THE PATIENT WAS STABILIZED." "THE SURGEON DECIDED TO LEAVE THE LEAD IN WHICH RESULTED IN THE DISTAL 3RD OF THE LOCKING STYLET BEING LEFT IN AS WELL." "THE PROCEDURE WAS NOT COMPLETED." NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED THE ADDITIONAL PROCEDURE OF REPAIRING OF A TORN VESSEL. THE PATIENT EXPERIENCED THE ADVERSE EFFECTS OF THE PROCEDURE BEING UNSUCCESSFUL AND NEEDING TO UNDERGO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES DRE COOK VASCULAR INC. LR-EVN-11.0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention