BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 15240138 · Received August 17, 2022

    Report

    Report Number
    2522007-2022-00018
    Event Type
    Death
    Date Received
    August 17, 2022
    Report Date
    October 25, 2022
    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/510K: K141148. 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. 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.

    Additional Manufacturer Narrative · 0

    D2B - PRODUCT CODE: DRE. G4 - PMA/510K: K141148. 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. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE COMPLAINT/EVENT ENTERED WITHIN TRACKWISE: "CARDIAC DEATH / TLE OPERATION DEATH / NON-CARDIAC DEATHS." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN.

    Description of Event or Problem · 0

    PERIOPERATIVE COMPLICATIONS WERE OBSERVED IN 7.1% OF THE PATIENTS. ONE PATIENT DIED DURING A TLE OPERATION AND THE OTHER THREE PATIENTS DIED IN-HOSPITAL (CARDIAC DEATH IN ONE PATIENT AND NON-CARDIAC TWO PATIENTS). THE JOURNAL ARTICLE STATES THAT MULTIPLE METHODS WERE USED INCLUDING DEVICES MANUFACTURED BY ANOTHER MANUFACTURER (GLIDELIGHT, PHILIPS WERE USED FOR 67.5% OF THE EXTRACTIONS): "MULTIPLE METHODS OF LEAD EXTRACTION WERE USED IN MANY CASES: LASER SHEATHS (GLIDELIGHT, PHILIPS) WERE USED FOR 67.5% OF LEADS, ROTATIONAL MECHANICAL SHEATHS (EVOLUTION RL, COOK MEDICAL) FOR 26.2% OF LEADS, AND MECHANICAL SHEATHS (COOK MEDICAL) FOR 16.6% OF LEADS. ALSO, SNARING TECHNIQUES WERE USED FOR 15.2% OF THE LEADS." THE ARTICLE DOES NOT IDENTIFY WHICH DEVICE OR DEVICES CAUSED OR MAY HAVE CONTRIBUTED TO THE PATIENT DEATHS OR THE PROCEDURE COMPLICATIONS LISTED IN TABLE 1 SECTION F.

    Description of Event or Problem · 0

    PERIOPERATIVE COMPLICATIONS WERE OBSERVED IN 7.1% OF THE PATIENTS. ONE PATIENT DIED DURING A TLE OPERATION AND THE OTHER THREE PATIENTS DIED IN-HOSPITAL (CARDIAC DEATH IN ONE PATIENT AND NON-CARDIAC TWO PATIENTS) THE JOURNAL ARTICLE STATES THAT MULTIPLE METHODS WERE USED INCLUDING DEVICES MANUFACTURED BY ANOTHER MANUFACTURER (GLIDELIGHT, PHILIPS WERE USED FOR 67.5% OF THE EXTRACTIONS): "MULTIPLE METHODS OF LEAD EXTRACTION WERE USED IN MANY CASES: LASER SHEATHS (GLIDELIGHT, PHILIPS) WERE USED FOR 67.5% OF LEADS, ROTATIONAL MECHANICAL SHEATHS (EVOLUTION RL, COOK MEDICAL) FOR 26.2% OF LEADS, AND MECHANICAL SHEATHS (COOK MEDICAL) FOR 16.6% OF LEADS. ALSO, SNARING TECHNIQUES WERE USED FOR 15.2% OF THE LEADS." THE ARTICLE DOES NOT IDENTIFY WHICH DEVICE OR DEVICES CAUSED OR MAY HAVE CONTRIBUTED TO THE PATIENT DEATHS OR THE PROCEDURE COMPLICATIONS LISTED IN TABLE 1 SECTION F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542526 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 COOK MEDICAL MECHANICAL SHEATHS| COOK MEDICAL MECHANICAL SHEATHS| GLIDELIGHT LASER SHEATH| GLIDELIGHT LASER SHEATH| PHILIPS LASER SHEATH| PHILLIPS LASER SHEATH