BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 15669071 · Received October 25, 2022

    Report

    Report Number
    2522007-2022-00021
    Event Type
    Death
    Date Received
    October 25, 2022
    Report Date
    January 12, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: DRE. PMA/5109K: 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

    D2B: PRODUCT CODE: DRE. G5: PMA/5109K): 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 OTHER THAN BY CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED INTO TRACKWISE: "ONE PATIENT DIED WITHIN 24HR AFTER THE PROCEDURE." PER THE JOURNAL ARTICLE: STEP BY STEP THROUGH THE YEARS¿HIGH VS. LOW ENERGY LEAD EXTRACTION USING ADVANCED EXTRACTION TECHNIQUES: "POST-PROCEDURAL COMPLICATIONS WERE SEEN IN 1.9% OF PROCEDURES, INCLUDING HEMATOMA REQUIRING DRAINAGE OR REINTERVENTION (0.6%), REVISION OF THE POCKET DUE TO OTHER REASONS (0.4%). TWO PATIENTS (0.3%) DEVELOPED SEVERE TRICUSPID REGURGITATION, ONE PATIENT EACH DEVELOPED LATE PERICARDIAL TAMPONADE, PNEUMOTHORAX AND PERIPHERAL THROMBOEMBOLISM. ONE PATIENT DIED WITHIN 24 H AFTER THE PROCEDURE. THERE WERE NO DIFFERENCES IN THE RATE OF COMPLICATIONS OR DEATH AFTER THE PROCEDURE IN ICD VS. NON-ICD GROUPS." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIVED DUE TO THE LOT WAS UNKNOWN SPECIFIC TO THIS COMPLAINT. 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 PER COMPLAINT FORM: ONE PATIENT IN THE ICD GROUP DEVELOPED REFRACTORY CARDIAC ARREST AND DIED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    AS PER COMPLAINT FORM: ONE PATIENT IN THE ICD GROUP DEVELOPED REFRACTORY CARDIAC ARREST AND DIED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556873 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 Unknown Death BYRD DILATOR - COOK.| BYRD DILATOR - COOK.| LLD - SPECTRANETICS.| LLD - SPECTRANETICS.| SLS II LASER SHEATH - SPECTRANETICS.| SLS II LASER SHEATH - SPECTRANETICS.| TIGHTRAIL - SPECTRANETICS.| TIGHTRAIL - SPECTRANETICS.