BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 7067039 · Received November 29, 2017

    Report

    Report Number
    2522007-2017-00039
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    October 30, 2017
    Report Date
    April 3, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    UDI-DI
    10827002237473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# 141148. INVESTIGATION SUMMARY: THE AFFECTED PRODUCT WAS NOT RETURNED FOR PHYSICAL EXAMINATION AND NO PHOTOGRAPHS WERE PROVIDED. THE COMPLAINT COULD ONLY BE CONFIRMED THROUGH CUSTOMER TESTIMONY. THE INSTRUCTIONS FOR USE WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF THE VASCULAR STRUCTURES OR THE MYOCARDIUM'. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE AND WILL BE MONITORED AND TRENDED VIA THE COMPLAIN HANDLING AND POST MARKET PROCESSES. A DEVICE HISTORY RECORD REVIEW FOR THIS LOT NUMBER WAS PERFORMED INCLUDING THE MANUFACTURING AND QUALITY CONTROL RECORDS. ALL STEPS WERE DOCUMENTED PER PROCEDURE BY TRAINED PERSONNEL AND THERE WERE NO SIGNS TO INDICATE THAT A NONCONFORMING DEVICE WAS RELEASED TO THE FIELD. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED IN ORDER TO COMPLETE A PHYSICAL EXAMINATION.

    Additional Manufacturer Narrative · 1

    NUMBER 510K #: K141148. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, WHILE THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS IN USE OVER A 1085-64 BSCI ICD LEAD WITH SPECTRANETICS LLD-EZ LOCKING STYLET IN PLACE TO RELEASE FIBROTIC BINDING SITES ALONG THE LEAD, AN EFFUSION WAS DETECTED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM. THIS EFFUSION WAS DETECTED SHORTLY AFTER THE EVOLUTION RL REACHED AN AREA IN THE RIGHT ATRIUM. CARDIOTHORACIC SURGERY AND HEART PUMP TEAM WERE CALLED IMMEDIATELY. THE HEART TEAM OPENED THE PATIENT'S CHEST TO EXPOSE THE HEART, AND THE TEAR IN THE ATRIUM WAS REPAIRED. THE PATIENT LATER RETURNED AND THE LEADS WERE SUCCESSFULLY SNARED. THE PATIENT IS REPORTEDLY DOING FINE. THE PRODUCT IS UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847497 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A 10827002237473

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention