BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 8451500 · Received March 26, 2019

    Report

    Report Number
    2522007-2019-00001
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    March 1, 2019
    Report Date
    August 27, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: DEVICE NOT RETURNED (4114). H6- EC METHOD CODE DESC - 2: HISTORICAL DATA ANALYSIS (4109). H6- EC RESULTS CODE DESC - 1: CHANGED TO NO FINDINGS AVAILABLE (3221). H6- EC CONCLUSIONS CODE DESC - 1: CHANGED TO KNOWN INHERENT RISK OF DEVICE (22). INVESTIGATION-EVALUATION: THE LR-EVN-11.0-RL WAS NOT RETURNED TO COOK VANDERGRIFT INC. FOR INVESTIGATION. THE CUSTOMER COMPLAINT/EVENT THAT WAS REPORTED PER THE TRACKWISE ENTRY: "AS REPORTED TO CUSTOMER RELATIONS: "THE 11FR COOK EVOLUTION TOOL WAS ADVANCED, LEAD WAS REMOVED AND PATIENT. HAD HYPOTENSIVE EPISODE. PERICARDIAL CENTESIS WAS DONE, CPR BEGUN, PERICARDIAL WINDOW DONE." THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET WAS NOT RETURNED, THE QUALITY ENGINEERING AND ENGINEERING DEPARTMENTS COULD NOT PERFORM A PHYSICAL INVESTIGATION. THE IFU FM-292WAS REVIEWED, AND ONE OF THE WARNINGS LISTED IS "DO NOT APPLY WEIGHTED TRACTION TO AN INSERTED LOCKING STYLET AS MYOCARDIAL AVULSION, HYPOTENSION, OR VENOUS WALL TEARING MAY RESULT." ALSO INCLUDED IN THE IFU ARE THE POTENTIAL ADVERSE EVENTS, WHICH INCLUDES "ACUTE HYPOTENSION. " SINCE THE DEVICE WAS NOT RETURNED IT IS INCONCLUSIVE IF THE CAUSE WAS DUE TO THE EVENTS MENTIONED IN THE IFU. WITHOUT THE DEVICE TO PHYSICALLY INVESTIGATE A DEFECT OF THE DEVICE OR THE MANUFACTURING PROCESS IS INCONCLUSIVE. THIS OCCURRENCE WILL CONTINUE TO BE MONITORED PER THE CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. THE DEVICE HISTORY RECORD (DHR), INCLUDING QUALITY CONTROL AND MANUFACTURING RECORDS, WERE REVIEWED. ALL PROCESS STEPS WERE COMPLETE AND SIGNED OFF BY TRAINED PERSONAL. A RISK ASSESSMENT WAS PERFORMED PER QERA 200724.1 AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB OF TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "THE 11FR COOK EVOLUTION TOOL WAS ADVANCED, LEAD WAS REMOVED AND PATIENT. HAD HYPOTENSIVE EPISODE. PERICARDIAL CENTESIS WAS DONE, CPR BEGUN, PERICARDIAL WINDOW DONE."

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT MEDICAL DEVICES: LIBERATOR BEACON TIP LOCKING STYLET (LR-OFA0), EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET 11FR. (LR-EVN-SH-11.0-RL). PMA/510(K): K141148. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CUSTOMER RELATIONS THAT DURING A LEAD EXTRACTION PROCEDURE,"THE 11FR COOK EVOLUTION TOOL WAS ADVANCED, THE LEAD WAS REMOVED AND THE PATIENT HAD A HYPOTENSIVE EPISODE." "PERICARDIAL CENTESIS WAS DONE, CPR BEGUN, AND A PERICARDIAL WINDOW DONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246694 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23746 N161262 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention