BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 16038263 · Received December 22, 2022

    Report

    Report Number
    2522007-2022-00028
    Event Type
    Death
    Date Received
    December 22, 2022
    Date of Event
    November 28, 2022
    Report Date
    February 1, 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

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. PRODUCT CODE: DRE PMA/510(K): 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/510(K): K141148. A DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OTHER THAN BY TESTIMONY. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "DEATH". PER JOURNAL ARTICLE: "THERE WAS NO OPERATIVE MORTALITY.", "MORTALITY 30 DAYS AFTER THE PROCEDURE WAS ONLY 1 CASE ((B)(4)). IT WAS A 74-YEAR-OLD PATIENT WITH DR (B)(6), WITH A CHRONICITY OF 17.75 YEARS WHO DIED IN THE FIRST MONTH OF FOLLOW-UP. AFTER REMOVAL OF THE ATRIAL LEAD, THE PATIENT DEVELOPED SEVERE HYPOTENSION (BLOOD PRESSURE: 60/30 MM HG) AND ELECTROMECHANICAL DISSOCIATION. THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TE) SHOWED A LARGE PERICARDIAL EFFUSION, WHICH REQUIRED STERNOTOMY AND ADVANCED CARDIOPULMONARY RESUSCITATION (CPR) MANEUVERS. SURGICAL EXPLORATION REVEALED AN APPROXIMATELY 1-CM TEAR IN THE RIGHT ATRIAL APPENDAGE, WHICH WAS REPAIRED WITH SUTURES. IN THE POSTOPERATIVE PERIOD, THE PATIENT PRESENTED PROLONGED INTUBATION, SEVERE CEREBRAL ISCHEMIA AND MULTISYSTEM FAILURE, DYING 20 DAYS AFTER THE PROCEDURE." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE LOT OF THE COMPLAINT DEVICE WAS UNKNOWN. 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

    THE ARTICLE IDENTIFYING ADVERSE EVENTS WAS A RETROSPECTIVE, SINGLE-CENTER STUDY OF A POPULATION OF PATIENTS RANGING BETWEEN OCTOBER 2009 AND DECEMBER 2018. THE COMPLICATIONS INVOLVED PERFORATION OF THE RIGHT ATRIUM IN PATIENT WITH DUAL-CHAMBER DDD PACEMAKER. AFTER REMOVAL OF THE ATRIAL LEAD, THE PATIENT DEVELOPED SEVERE HYPOTENSION (BLOOD PRESSURE: 60/30 MM HG) AND ELECTROMECHANICAL DISSOCIATION. THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TE) SHOWED A LARGE PERICARDIAL EFFUSION, WHICH REQUIRED STERNOTOMY AND ADVANCED CARDIOPULMONARY RESUSCITATION (CPR) MANEUVERS. SURGICAL EXPLORATION REVEALED AN APPROXIMATELY 1-CM TEAR IN THE RIGHT ATRIAL APPENDAGE, WHICH WAS REPAIRED WITH SUTURES. REPORT IDENTIFIES RIGHT ATRIUM PERFORATION IN ONE PATIENT WHO DIED IN THE FIRST MONTH OF FOLLOW-UP. IN THE POSTOPERATIVE PERIOD, THE PATIENT PRESENTED PROLONGED INTUBATION, SEVERE CEREBRAL ISCHEMIA AND MULTISYSTEM FAILURE, DYING 20 DAYS AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    THE ARTICLE IDENTIFYING ADVERSE EVENTS WAS A RETROSPECTIVE, SINGLE-CENTER STUDY OF A POPULATION OF PATIENTS RANGING BETWEEN (B)(6) 2009 AND (B)(6) 2018. THE COMPLICATIONS INVOLVED PERFORATION OF THE RIGHT ATRIUM IN PATIENT WITH DUAL-CHAMBER DDD PACEMAKER. AFTER REMOVAL OF THE ATRIAL LEAD, THE PATIENT DEVELOPED SEVERE HYPOTENSION (BLOOD PRESSURE: 60/30 MM HG) AND ELECTROMECHANICAL DISSOCIATION. THE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TE) SHOWED A LARGE PERICARDIAL EFFUSION, WHICH REQUIRED STERNOTOMY AND ADVANCED CARDIOPULMONARY RESUSCITATION (CPR) MANEUVERS. SURGICAL EXPLORATION REVEALED AN APPROXIMATELY 1-CM TEAR IN THE RIGHT ATRIAL APPENDAGE, WHICH WAS REPAIRED WITH SUTURES. REPORT IDENTIFIES RIGHT ATRIUM PERFORATION IN ONE PATIENT WHO DIED IN THE FIRST MONTH OF FOLLOW-UP. IN THE POSTOPERATIVE PERIOD, THE PATIENT PRESENTED PROLONGED INTUBATION, SEVERE CEREBRAL ISCHEMIA AND MULTISYSTEM FAILURE, DYING 20 DAYS AFTER THE PROCEDURE. HYPOTENSION, PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841544 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 LR-OFA01.| LR-OFA01.