BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 8785767 · Received July 12, 2019

    Report

    Report Number
    2522007-2019-00004
    Event Type
    Death
    Date Received
    July 12, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 20, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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). H10- ADDED SUMMARY OF INVESTIGATION: INVESTIGATION-EVALUATION: NO DEVICE WAS RETURNED TO CVI. THEREFORE, A PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. THE COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "THE VENTRICULAR LEAD CAME OFF AND SEVERE ACUTE BLOOD HYPOTENSION AND CARDIAC ARREST OCCURRED". THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED. AND THERE WERE NO SIGNS TO INDICATE, THAT NONCONFORMING PRODUCT WAS MANUFACTURED AND SHIPPED TO THE FIELD. THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND POST MARKED SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED PER QERA 200306.1 AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB OF TRACKWISE. PER IFU (D00078684, REV002): "IF EXCESSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATHES, CONSIDER AN ALTERNATE APPROACH. EXCESSIVE FORCE WITH SHEATHS, INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET USED INTRAVASCULARLY, MAY RESULT IN DAMAGE TO THE VASCULAR SYSTEM REQUIRING SURGICAL REPAIR". AND "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY BY PHYSICIANS KNOWLEDGEABLE IN THE TECHNIQUES AND DEVICES FOR CATHETER/LEAD REMOVAL". 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

    IT WAS REPORTED, THAT DURING A LEAD EXTRACTION PROCEDURE. UTILIZING THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-13.0-RL). THE VENTRICULAR PACEMAKER LEAD WAS REMOVED, AND THE PATIENT BEGAN TO EXPERIENCE ACUTE HYPOTENSION AND CARDIAC ARREST, DUE TO A POSSIBLE LACERATION OF THE HEART. PERICARDIOCENTESIS AND RESUSCITATION MANEUVERS WHERE PERFORMED FOR 30 MINUTES WITHOUT SUCCESS AND PATIENT EXPIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT MEDICAL DEVICES: FEMORAL ARTERY: 4FR CORDIS, VEIN INTRODUCER: 6FR CORDIS, TEMPORARY PACEMAKER, CATHETER: ST. JUDE-ABBOT SUPREME. (B)(6). PMA/510(K): K14118. (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 THAT DURING A LEAD EXTRACTION PROCEDURE UTILIZING THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-13.0-RL) THE VENTRICULAR PACEMAKER LEAD WAS REMOVED, AND THE PATIENT BEGAN TO EXPERIENCE ACUTE HYPOTENSION AND CARDIAC ARREST DUE TO A POSSIBLE LACERATION OF THE HEART. PERICARDIOCENTESIS AND RESUSCITATION MANEUVERS WHERE PERFORMED FOR 30 MINUTES WITHOUT SUCCESS AND PATIENT EXPIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580098 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23747 N162329 10827002237473

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death