BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 13659680 · Received March 3, 2022

    Report

    Report Number
    2522007-2022-00007
    Event Type
    Injury
    Date Received
    March 3, 2022
    Date of Event
    February 2, 2022
    Report Date
    May 2, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. G4: PMA/510(K): K141148. THE DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S TESTIMONY/LITERATURE IS THE CONFIRMATION OF THE COMPLAINT. THE COMPLAINT ENTERED WITHIN TRACKWISE: "DURING THE LEAD EXTRACTION THIS MORNING THE PATIENT SUFFERED A PERICARDIAL EFFUSION/TAMPONADE." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. 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

    IT WAS REPORTED TO COOK THAT A LEAD EXTRACTION PROCEDURE WAS PERFORMED AT (B)(6)HOSPITAL ON (B)(6) 2022. THE PATIENT HAD 23 YEAR OLD LEADS IN PLACE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION/TAMPONADE OCCURRED SO A PERICARDIOCENTESIS SET WAS USED TO DRAIN THE PERICARDIAL EFFUSION. PROCEDURE WAS COMPLETED AND IT WAS REPORTED THAT THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683094 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE COOK VANDERGRIFT INC G23746 N183234 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention