BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 9682072 · Received February 7, 2020

    Report

    Report Number
    2522007-2020-00011
    Event Type
    Death
    Date Received
    February 7, 2020
    Date of Event
    January 9, 2020
    Report Date
    August 20, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: DEVICE NOT RETURNED (4114). H6- EC RESULTS CODE DESC - 1: CHANGED TO NO FINDINGS AVAILABLE (3221). H6- EC RESULTS CODE DESC - 2: HISTORICAL DATA ANALYSIS (4109). 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: " EVERYTHING WAS STABLE, WHILE CLOSING THE WOUND PATIENT DIED BECAUSE OF LOT BLOOD LOSS AND WEAK HEART." 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT MEDICAL PRODUCTS: LIBERATOR LOCKING STYLET LR-OFA01, LR-OTE-N, LR-EVN-SH-9.0-RL. OCCUPATION: CUSTOMER CONTACT OCCUPATION: PHYSICIAN. PMA/510(K): K141148. TYPE OF INVESTIGATION NOT YET DETERMINED (4118). (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

    DR. (B)(6) STATED HE WOULD LIKE TO REPORT AN ADVERSE EVENT HAPPENED AFTER USE OF EVOLUTION RL DURING LEAD EXTRACTION. AFTER SUCCESSFUL EXPLANATION WITH LR-EVN-RL 11FR. AND WOUND CLOSURE, BLOOD PRESSURE DROP, TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED EXCESSIVE FLUID ACCUMULATION AROUND THE HEART CONSISTENT WITH CARDIAC TAMPONADE, DRAINAGE WAS NOT SUCCESSFUL. THORACOTOMY IMMEDIATELY PERFORMED AND THE PERFORATION OF THE HEART WALL WAS SUTURED SUCCESSFULLY. EVERYTHING WAS STABLE, WHILE CLOSING THE WOUND, HOWEVER, PATIENT DIED BECAUSE OF EXCESSIVE BLOOD LOSS AND WEAK HEART. DR. (B)(6) IS AWARE THAT ANY OTHER PROCEDURE COULD HAVE CAUSED THIS COMPLICATION. HE DOESN'T BLAME OUR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146563 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23746 N167589 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death