BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 14852120 · Received June 29, 2022

    Report

    Report Number
    2522007-2022-00017
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 20, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: DRE. PMA/510(K): K141148. 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. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. D2B- PRODUCT CODE: DRE G4- PMA/510(K): K141148 INVESTIGATION - EVALUATION NO DEVICE WAS RETURNED ON THIS COMPLAINT DUE TO THE CUSTOMER DISCARDING THE DEVICE, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OTHER THAN BY TESTIMONY. THE CUSTOMER'S COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "INCREASE IN PERICARDIAL EFFUSION". PER COMPLAINT INFORMATION: "PER REP - 02JUN2022 - THEY NOTICED AN INCREASE IN PERICARDIAL EFFUSION WHILE TRYING TO EXTRACT ONE OF THE 29 YEAR OLD LEADS. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COOK DEVICES PERFORMED WELL AND AS EXPECTED. SUBSEQUENTLY, THEY PERFORMED A STERNOTOMY TO REPAIR A PERFORATION IN THE RIGHT ATRIUM. THE DOCTOR THOUGHT THAT THE PATIENT WAS GOING TO NEED A STERNOTOMY ANYWAY DUE TO HOW OLD THE LEADS WERE." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONFIRMED DUE TO THE LOT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN 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

    PER COMPANY REPRESENTATIVE - (B)(6) 2022 - THEY NOTICED AN INCREASE IN PERICARDIAL EFFUSION WHILE TRYING TO EXTRACT ONE OF THE 29 YEAR OLD LEADS. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COOK DEVICES PERFORMED WELL AND AS EXPECTED. SUBSEQUENTLY, THEY PERFORMED A STERNOTOMY TO REPAIR A PERFORATION IN THE RIGHT ATRIUM. THE DOCTOR THOUGHT THAT THE PATIENT WAS GOING TO NEED A STERNOTOMY ANYWAY DUE TO HOW OLD THE LEADS WERE.

    Description of Event or Problem · 0

    PER COMPANY REPRESENTATIVE - 02JUN2022 - THEY NOTICED AN INCREASE IN PERICARDIAL EFFUSION WHILE TRYING TO EXTRACT ONE OF THE 29 YEAR OLD LEADS. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COOK DEVICES PERFORMED WELL AND AS EXPECTED. SUBSEQUENTLY, THEY PERFORMED A STERNOTOMY TO REPAIR A PERFORATION IN THE RIGHT ATRIUM. THE DOCTOR THOUGHT THAT THE PATIENT WAS GOING TO NEED A STERNOTOMY ANYWAY DUE TO HOW OLD THE LEADS WERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749789 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 51 YR Female Required Intervention| H