BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 3181445 · Received June 14, 2013

    Report

    Report Number
    2522007-2013-00018
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    March 2, 2013
    Report Date
    June 13, 2013
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K010055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO INFO SUPPLIED TO TRACKWISE, THIS PRODUCT IS NOT BEING RETURNED FOR EVAL. AS THE DEVICES HAVE NOT BEEN RETURNED FOR EVAL 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 IRELAND REPORTED FOR THE CUSTOMER, "11F AND THEN 13F EVOLUTION DEVICES USED TO DISSECT THE RV ICD LEAD. DEVICE SUCCESSFULLY PASSED BY THE SVC/RA JUNCTION AND THE LEAD WAS EXTRACTED COMPLETELY. AFTER 2 MINUTES, THE PT'S BLOOD PRESSURE DROPPED. CHEST COMPRESSIONS (CPR) WAS COMMENCED AND CARDIAC SURGEON WAS CALLED. RIGHT SIDED THORACOTOMY PERFORMED, 2CM JAGGED EDGED TEAR IN THE POSTERIOR SVC/RA JUNCTION WHERE THE SVC COIL HAD BEEN EMBEDDED. TEAR WAS REPAIRED BUT THIS REPAIR ENCLOSED THE DISTAL SECTION OF THE RA LEAD. DECISION WAS MADE TO CUT THE REMAINDER OF THE RA LEAD (SUPERIOR) AND TRANSFER PT TO ICU". INFO FROM REGIONAL MANAGER: "YES A CONVERSATION WITH BOTH, THE SURGEON (WHO OPENED THE CHEST) AND THE PHYSICIAN (WHO PERFORMED THE EXTRACTION). NEITHER FELT THAT THE USE OF THE DEVICE DEFINITELY CAUSED THE TEAR, RATHER THAT THE POSITION OF THE INDWELLING LEAD; ALONG WITH THE LENGTH OF TIME IT HAD BEEN INSITU AND THE PROBABLE ADHESIONS AROUND THE LEAD HAD CAUSED IT TO ERODE INTO THE VESSEL WALL. ATTACHED IS A SCREEN SHOT IMAGE OF THE X-RAY PRIOR TO THE EXTRACTION CASE". ADD'L INFO FROM REGIONAL MANAGER: "PLEASE NOTE THE FOLLOWING "NEITHER DR (B)(6) NOR MR (B)(6) WANTED THE EVENT TO BE REPORTED AS THEY DID NOT FEEL THAT THE DEVICE DEFINITELY CAUSED THE EVENT". "NEITHER DR (B)(6) NOR (B)(6) WISH TO BE CONTACTED REGARDING THIS REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271461 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. LR-EVN-13.0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R