BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

    MDR report key: 13581259 · Received February 22, 2022

    Report

    Report Number
    2522007-2022-00006
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    January 26, 2022
    Report Date
    May 5, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    00827002250840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE: DRE. G5: PMA/510(K): K141148. NO DEVICE WAS RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE COMPLAINT COULD NOT BE CONFIRMED. THE COMPLAINT/EVENT ENTERED WITHIN TRACKWISE: "THE METAL STABILIZING TIP BROKE OFF IN THE PATIENT." PER COMPLAINT INFORMATION: "THE METAL STABILIZING TIP BROKE OFF IN THE PATIENT IN THE UPPER LEFT CHEST. THEY WERE ABLE TO RETRIEVE IT WITH NO HARM TO THE PATIENT BUT THE REP HAS NOT YET CONFIRMED THE METHOD USED TO RETRIEVE IT." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROLS AND THERE WERE NO SIGNS TO INDICATE THAT NONCONFORMING PRODUCT WAS MANUFACTURED AND SHIPPED TO THE FIELD. THIS COMPLAINT TYPE WILL CONTINUE TO BE MONITORED, TRACKED AND TRENDED PER CVI'S COMPLAINT HANDLING AND POST MARKET SURVEILLANCE 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

    AS REPORTED PER SALES REPRESENTATIVE ON 26JAN2022; THE METAL STABILIZING TIP BROKE OFF IN THE PATIENT IN THE UPPER LEFT CHEST. THEY WERE ABLE TO RETRIEVE IT WITH NO HARM TO THE PATIENT BUT THE SALES REPRESENTATIVE HAS NOT YET CONFIRMED THE METHOD USED TO RETRIEVE IT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632294 LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH DRE COOK VANDERGRIFT INC G25084 N167924 00827002250840

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention