BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 9011772 · Received September 12, 2019

    Report

    Report Number
    2522007-2019-00009
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    August 27, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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 CONCLUSIONS CODE DESC - 1: CHANGED TO KNOWN INHERENT RISK OF DEVICE (22). H10- ADDED SUMMARY OF INVESTIGATION. INVESTIGATION-EVALUATION: NO LR-EVN DEVICES WERE RETURNED TO COOK VANDERGRIFT INC. THIS COMPLAINT WAS ISSUED DUE TO A JOURNAL ARTICLE REVIEW: CLINICAL RESEARCH, ON BEHALF OF THE EUROPEAN SOCIETY OF CARDIOLOGY. "LEAD EXTRACTION FOR CARDIAC IMPLANTABLE ELECTRONIC DEVICE INFECTION: COMPARABLE COMPLICATION RATES WITH OR WITHOUT ABANDONED LEADS". THE COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "INTRAPERICARDIAL, NO PATIENT DEATH". PER ARTICLE: "THE THREE OTHER PATIENTS WITH MAJOR COMPLICATIONS IN GROUP 2 HAD INTRAPERICARDIAL TAMPONADE: TWO DURING A FEMORAL APPROACH AND ONE WITH AN EVOLUTION RL MECHANICAL ROTATIONAL SHEATH (COOK). ALL THREE RECOVERED COMPLETELY AFTER ACUTE SURGERY." THE DEVICE WAS NOT RETURNED, THEREFORE A PHYSICAL INVESTIGATION OF THE DEVICE WAS NOT PERFORMED. THE QUALITY ASSURANCE DEPARTMENT REVIEWED THE PROVIDED ARTICLE. A MANUFACTURING FAILURE/DEFECT OF THE DEVICE COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. ADVERSE PHYSIOLOGICAL RESPONSE IS A KNOW FAILURE MODE OF THIS DEVICE. THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND THE POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED VIA QERA 200306.2 AND DOCUMENTED IN THE COMPLAINT SUMMARY 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. - ATTACHMENT: [BRACKE - LEAD EXTRACTION FOR CARDIAC IMPLANTABLE ELECTRONIC DEVICE INFECTION HIGHLIGHTED.PDF]

    Description of Event or Problem · 0

    AS REPORTED IN LITERATURE FINING, "THE THREE OTHER PATIENTS WITH MAJOR COMPLICATIONS IN GROUP 2 HAD INTRAPERICARDIAL TAMPONADE: TWO DURING A FEMORAL APPROACH AND ONE WITH AN EVOLUTION RL MECHANICAL ROTATIONAL SHEATH (COOK). ALL THREE RECOVERED COMPLETELY AFTER ACUTE SURGERY." INTRAPERICARDIAL, NO PATIENT DEATH.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. 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

    AS REPORTED IN THE LITERATURE FINDING, THE FOLLOWING ADVERSE EVENT OCCURRED DURING A CASE STUDY FOR LEAD EXTRACTION PROCEDURES WHICH TOOK PLACE BETWEEN 2006 AND 2017, IN WHICH "THE THREE OTHER PATIENTS WITH MAJOR COMPLICATIONS IN GROUP 2 HAD INTRAPERICARDIAL TAMPONADE: TWO DURING A FEMORAL APPROACH AND ONE WITH AN EVOLUTION RL MECHANICAL ROTATIONAL SHEATH (COOK), (LR-EVN-11.0-RL). ALL THREE RECOVERED COMPLETELY AFTER ACUTE SURGERY." THE ADVERSE EVENT SITED IN THIS EXCERPT, WHICH THIS REPORT IS INTENDED TO ADDRESS, IS INDICATED TO BE AN INTRAPERICARDIAL TAMPONADE FROM THE SUPERIOR APPROACH WHICH REQUIRED SURGICAL INTERVENTION. NO OTHER CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795083 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention