BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 7123856 · Received December 15, 2017

    Report

    Report Number
    2522007-2017-00046
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 20, 2017
    Report Date
    March 13, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    UDI-DI
    10827002237466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. UPDATES: 510(K) K141148 DEVICE NOT RETURNED TO MANUFACTURER. ADDED SUMMARY OF INVESTIGATION. INVESTIGATION SUMMARY: THE REPORT EVENT WAS UNABLE TO BE CONFIRMED AS DEVICE WAS NOT RECEIVED. THE QUALITY ENGINEERING AND ENGINEERING DEPARTMENTS COULD NOT PERFORM AN EVALUATION, THEREFORE, A DETERMINATION IF THE DEVICE WAS DEFECTIVE IS INCONCLUSIVE. THE IFU WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM'. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE AND WILL BE MONITORED AND TRENDED VIA THE COMPLAINT HANDLING AND POST MARKET PROCESSES. A DEVICE HISTORY RECORD REVIEW FOR THIS LOT NUMBER (N147359) WAS PERFORMED INCLUDING BOTH 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): K141148. 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 USER FACILITY REPORTED DURING A CARDIAC LEAD EXTRACTION PROCEDURE, THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS USED TO REMOVE THE LEAD. DURING ACTIVATION AT TRANSITION VENA CAVA SUPERIOR/RIGHT ATRIUM, THE EVOLUTION RL DAMAGED THE RA LEAD. THE LEAD WAS REMOVED SUCCESSFULLY BUT RIGHT AFTER THE TENSION DROPPED, AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. A PERICARDIAL PUNCTURE WAS UTILIZED TO DRAIN BLOOD AND A THORACOTOMY TO SUTURE THE PERFORATION WAS USED TO STOP THE BLEEDING. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO REPORTED FURTHER ADVERSE EVENTS AFTER THE COMPLETION OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902236 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 42 DA Required Intervention LOCKING STYLET LR-OFA01, ONE TIE LR-OTE-N.