BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 1185003 · Received October 2, 2008

    Report

    Report Number
    2522007-2008-00008
    Event Type
    Death
    Date Received
    October 2, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 30, 2008
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K010055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FIELD CLINICAL SPECIALIST REPORTED, "THE PT PRESENTED WITH TWO LEADS: A PACING LEAD IN THE ATRIUM AND AN ICD LEAD IN THE VENTRICLE. THE TWO LEADS WERE FIRMLY ADHERED WITHIN THE VENOUS SYSTEM. IT WAS NOT POSSIBLE TO REMOVE THE ICD LEAD ALONE WITHOUT TO DAMAGE THE ATRIAL LEAD. THIS WAS THE REASON WHY THEY DECIDED TO REMOVE THE ATRIAL LEAD. AT FIRST THE PHYSICIAN SECURED THE LIBERATOR LOCKING STYLET IN EACH LEAD AND THEN HE TRIED TO REMOVE THE LEAD FROM IT'S ATTACHMENT TO THE VENOUS WALL WITH THE BYRD DILATOR SHEATH, LR-PPLBES-10.0. DURING THIS ACTION THE ATRIAL LEAD BECAME TWISTED AROUND THE ICD LEAD. NEXT HE TRIED TO REMOVE THE ATRIAL LEAD WITH THE BYRD DILATOR LR-PPLBES-8.5. THIS WAS NOT SUCCESSFUL, TRIED TO REMOVE THE TWO LEADS WITH A 13F BYRD DILATOR, LR-PPLBES-13. WITH THE 13F DILATOR SHEATH HE DID DETACH THE ICD LEAD FROM THE VENOUS WALL. AS THE SUPERIOR VENA CAVA WAS OCCLUDED. DURING THE WHOLE PROCEDURE THE PT HAD BLOOD PRESSURE PROBLEMS. AFTER THAT HE USED THE 13 PERFECTA EDS SHEATH. WITH THIS SHEATH HE WAS ABLE TO ADVANCE FORWARD TO THE COIL ON THE ICD LEAD. HE SWITCHED TO THE 13F EVOLUTION SHEATH AND PROGRESSES OVER AND PAST THE COILS AND REMOVED THE LEAD COMPLETELY. THEN HE USED A 9F EVOLUTION SHEATH FOR THE ATRIAL LEAD. THE SHEATH WAS REMOVED AND AFTER A SOFT TRACTION WITHOUT A SHEATH ON THE LEAD WAS APPLIED, THE BLOOD PRESSURE HAD DROPPED AND UNDER THE X-RAY THEY SAW A BIG MEDIASTINAL SHADOW. THEY PERFORMED AN EMERGENCY THORACOTOMY AND THEY FOUND THE BLEEDING IMMEDIATELY AND STOPPED IT BUT THE CARDIAC SITUATION FROM THE PT COULD NOT BE RECTIFIED. PRODUCT HAS NOT BEEN EVALUATED. PRODUCT RETURNED IN 2008. EVAL WILL BE COMPLETED AT A LATER DATE. PT EXPIRED SAME DAY (2008).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. LR-EVN-13.0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death