BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 17151459 · Received June 19, 2023

    Report

    Report Number
    2522007-2023-00005
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    May 24, 2023
    Report Date
    September 19, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 ¿ PMA/510(K): K141148. 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. 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 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 CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "BLOOD PRESSURE DROPPING." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT WILL BE MONITORED, TRACKED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB WITHIN 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 COMPLAINT FORM - 3X LOCKING STYLETS AND ONE-TIES WERE USED. THE 13FR EVOLUTION WAS ADVANCED TO THE BEGINNING OF THE DISTAL COIL AND THE LEAD EXTRACTED. THE PHYSICIAN NOTICED BLOOD PRESSURE DROPPING.

    Description of Event or Problem · 0

    PER COMPLAINT FORM - 3X LOCKING STYLETS AND ONE-TIES WERE USED. THE 13FR EVOLUTION WAS ADVANCED TO THE BEGINNING OF THE DISTAL COIL AND THE LEAD EXTRACTED. THE PHYSICIAN NOTICED BLOOD PRESSURE DROPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746459 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 72 YR Male Other LOCKING STYLETS| LOCKING STYLETS| ONE-TIES| ONE-TIES