BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 10530971 · Received September 14, 2020

    Report

    Report Number
    2522007-2020-00018
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 20, 2020
    Report Date
    June 3, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D2: PRODUCT CODE: DRE. D11: CONCOMITANT DEVICES: SPECTRANETICS DVX/GLIDELIGHT 12FR LASER SHEATH/500-301, SPECTRANETICS DVX/LEAD LOCKING DEVICE (LLD)/58-067. G5: PMA/510(K): K14118. 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 REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "THE LEAD WAS SUCCESSFULLY EXTRACTED. FOLLOWING THE EXTRACTION OF THE LEAD FROM THE RIGHT VENTRICLE, AND WHILE ATTEMPTING TO GAIN ACCESS WITH A WIRE, AN EFFUSION WAS DETECTED." THE CASE WAS CONVERTED TO AN OPEN PROCEDURE TO REACH AND STOP THE EFFUSION.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. CONCOMITANT DEVICES: SPECTRANETICS DVX/GLIDELIGHT 12FR LASER SHEATH/500-301, SPECTRANETICS DVX/LEAD LOCKING DEVICE (LLD)/58-067. PMA/510(K): K14118. (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

    IT WAS REPORTED TO CUSTOMER RELATIONS THAT THE PATIENT'S LEAD WAS SUCCESSFULLY EXTRACTED USING THE COOK EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-11.0-RL) . HOWEVER, FOLLOWING THE EXTRACTION OF THE LEAD FROM THE RIGHT VENTRICLE, AND WHILE ATTEMPTING TO GAIN ACCESS WITH A WIRE, AN EFFUSION WAS DETECTED. THE PROCEDURE WAS THEN CONVERTED TO AN OPEN PROCEDURE TO REACH AND STOP THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992860 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 64 YR Required Intervention