BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 16956281 · Received May 18, 2023

    Report

    Report Number
    2522007-2023-00002
    Event Type
    Death
    Date Received
    May 18, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 21, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE 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

    G4 ¿ PMA/510(K): K141148. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT ENTERED WITHIN TRACKWISE: "PATIENT'S BLOOD PRESSURE DROPPED, PROCEDURE ABORTED LEADING TO INTERVENTION." PER COMPLAINT INFORMATION: " AS THE 13FR EVOLUTION WITH STEADYSHEATH WAS BEING ADVANCED OVER THE LEAD, THROUGH THE RIGHT SUBCLAVIAN VEIN, THE PATIENT'S BLOOD PRESSURE DROPPED. THE LEAD EXTRACTION PROCEDURE WAS THEN ABORTED, AND THE CARDIOVASCULAR SURGEON AND THE HEART TEAM INTERVENED TO LOCATE ANY POSSIBLE BLEEDING SITES AND STOP THE BLEEDING." 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. 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

    REPORTED BY THE DISTRICT MANAGER (DM) ON BEHALF OF THE CUSTOMER VIA COMPLAINT COMMUNICATION FORM - AS THE 13FR EVOLUTION WITH STEADYSHEATH WAS BEING ADVANCED OVER THE LEAD, THROUGH THE RIGHT SUBCLAVIAN VEIN, THE PATIENT'S BLOOD PRESSURE DROPPED. THE LEAD EXTRACTION PROCEDURE WAS THEN ABORTED, AND THE CARDIOVASCULAR SURGEON AND THE HEART TEAM INTERVENED TO LOCATE ANY POSSIBLE BLEEDING SITES AND STOP THE BLEEDING.

    Description of Event or Problem · 0

    REPORTED BY THE DISTRICT MANAGER (DM) ON BEHALF OF THE CUSTOMER VIA COMPLAINT COMMUNICATION FORM - AS THE 13FR EVOLUTION WITH STEADYSHEATH WAS BEING ADVANCED OVER THE LEAD, THROUGH THE RIGHT SUBCLAVIAN VEIN, THE PATIENT'S BLOOD PRESSURE DROPPED. THE LEAD EXTRACTION PROCEDURE WAS THEN ABORTED, AND THE CARDIOVASCULAR SURGEON AND THE HEART TEAM INTERVENED TO LOCATE ANY POSSIBLE BLEEDING SITES AND STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907482 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Death 11FR SHORTIE RL| 11FR SHORTIE RL| 12FR CURVED INNER SHEATH| 12FR CURVED INNER SHEATH| 13FR EVOLUTION STEADY SHEATH| 13FR EVOLUTION STEADY SHEATH| 13FR NEEDLE'S EYE SNARE| 13FR NEEDLE'S EYE SNARE| 16FR CURVED INTRODUCER SHEATH| 16FR CURVED INTRODUCER SHEATH| LIBERATOR LOCKING STYLET| LIBERATOR LOCKING STYLET| ONE-TIE COMPRESSION COIL| ONE-TIE COMPRESSION COIL| STEADYSHEATH 13.0FR| STEADYSHEATH 13.0FR