BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 13827290 · Received March 19, 2022

    Report

    Report Number
    2522007-2022-00010
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    February 18, 2022
    Report Date
    May 2, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 QUALITY ENGINEERING REVIEW.

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE: DRE. G5: PMA/510(K): K141148. A DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE COMPLAINT/EVENT ENTERED WITHIN TRACKWISE: "DAMAGE OF THE SUPERIOR VENA CAVA (SVC) RESULTING IN OPEN CHEST SURGERY. 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 THAT A PATIENT EXPERIENCED A SVC TEAR AND BLOOD PRESSURE DROP DURING A LEAD EXTRACTION PROCEDURE. REMOVAL OF THE ICD LEAD COMMENCED USING THE EVOLUTION 11FR SHORTIE TO PEEL OFF THE ADHESION AT THE INSERTION AREA, THEN EVOLUTION 11FR RL (LR-EVN-11.0-RL) WAS ADVANCED TO NEAR THE ENTRANCE OF THE SVC TO PEEL OFF THE ADHESION. A PHILIP'S GLIDELITE 12FR WAS THEN USED AND THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. DEVICE USER TEMPORARILY CONDUCTED HEMOSTATIC TREATMENT WITH A BALLOON CATHETER (BRIDGE OCCLUSION BALLOON CATHETER/ PHILIP) AND THEN PERFORMED ON-PUMP THORACOTOMY FOR HEMOSTASIS AND THE THREE REMAINING LEADS (THE VENTRICLE LEAD IN THE RIGHT AND THE LEFT ATRIAL AND VENTRICLE LEADS) WERE REMOVED AND THE INCISION WAS CLOSED. THE PATIENT WAS RETURNED TO THE ICU. THE SEVERITY OF THE COMPLICATION AND THE PATIENT'S CONDITION HAVE NOT BEEN SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532192 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23746 N180151 10827002237466

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention