BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 20224257 · Received September 16, 2024

    Report

    Report Number
    2522007-2024-00032
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 21, 2024
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. THE EVENT IS CURRENTLY UNDER INVESTIGATION. 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. D2B ¿ PRODUCT CODE: DRE. G5 ¿ PMA/510(K): K141148 . 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 INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "BLOOD PRESSURE DROPPED." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT 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. G5 ¿ PMA/510(K): K141148. 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 INITIALLY REPORTED TO CUSTOMER RELATIONS: A 59-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION WITH SUPERIOR APPROACH INSTRUMENTS PROCEDURE IN WHICH THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, G23747, WAS USED. 2X LOCKING STYLETS, 2X ONE-TIES WERE USED. THE 11FR SHORTIE AND 13FR EVOLUTION EXTRACTED THE RA LEAD. THE 11FR SHORTIE THEN 13FR EVOLUTION WERE ADVANCED PART WAY ONTO THE RV LEAD, AND THE LEAD EXTRACTED. THE PHYSICIAN NOTICED BLOOD PRESSURE DROPPING.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 59-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION WITH SUPERIOR APPROACH INSTRUMENTS PROCEDURE IN WHICH THE LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, G23747, WAS USED. 2X LOCKING STYLETS, 2X ONE-TIES WERE USED. THE 11FR SHORTIE AND 13FR EVOLUTION EXTRACTED THE RA LEAD. THE 11FR SHORTIE THEN 13FR EVOLUTION WERE ADVANCED PART WAY ONTO THE RV LEAD, AND THE LEAD EXTRACTED. THE PHYSICIAN NOTICED BLOOD PRESSURE DROPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403934 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC G23747 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other G25084/LR-TSS-13.0| G26550/LR-OFA01| G31923/LR-TSS-SH-11.0| G31929/LR-OTE-N| LR-EVN-SH-11.0-RL| LR-OFA01| LR-OTE-N