BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 3431079 · Received October 22, 2013

    Report

    Report Number
    2522007-2013-00034
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    September 20, 2013
    Report Date
    October 22, 2013
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DRE
    PMA / PMN Number
    K061000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) LR-EVN-9.0 DEVICE WAS RETURNED ALONG WITH ITS OUTER SHEATH. THE INNER SHEATH WAS RETURNED IN TWO PIECES. THE DISTAL PORTION WAS RETURNED ENTWINED WITH A CARDIAC LEAD. BOTH THE DISTAL AND PROXIMAL PORTION OF THE INNER SHEATH WERE TWISTED AND PINCHED OFF. THERE ARE NO MARKS INDICATING THAT THE SHEATH WAS DAMAGED PRIOR TO USAGE. THE DEVICE APPEARS TO HAVE ENCOUNTERED RESISTANCE AT THE DISTAL TIP, THUS PREVENTING FREE ROTATION OF THE INNER SHEATH OF THE EVOLUTION DEVICE. THIS RESISTANCE CAUSED THE APPLICATION OF FORCE TO THE INNER SHEATH, WHICH THEN BUCKLED AND SHEARED OFF. NO ADDITIONAL DETAILS WERE PROVIDED TO DETERMINE THE ROOT CAUSE OF DEVICE FAILURE. THERE IS NO EVIDENCE THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    COOK (B)(4) REPORTED FOR THE CUSTOMER, "DURING THE PROCEDURE, THE CUTTING TIP BROKE OFF." THE REP ADVISED HE DOES NOT HAVE DETAILS IN THE EVENT YET BUT WILL OBTAIN THE INFO. (B)(4). THE TIP/BROKEN OFF SECTION WAS REMOVED USING A VERY THIN EV3 LASSO SNARE IN AN ADDITIONAL PROCEDURE. NO ADVERSE EFFECTS ON THE PT WERE REPORTED TO HAVE OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540899 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC. N113521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening