BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 7966496 · Received October 15, 2018

    Report

    Report Number
    2522007-2018-00027
    Event Type
    Death
    Date Received
    October 15, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 21, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    UDI-DI
    10827002237473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K): K141148. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K141148. ADDED SUMMARY OF INVESTIGATION: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED FOR A PHYSICAL EVALUATION, THEREFORE A DETERMINATION IF A DEVICE MALFUNCTION OCCURRED IS INCONCLUSIVE. THE INSTRUCTIONS FOR USE WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM'. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE AND WILL BE MONITORED AND TRENDED VIA THE COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE COMPLETED PER QERA/RISK ASSESSMENT FOR THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER WAS PERFORMED INCLUDING THE MANUFACTURING AND QUALITY CONTROL RECORDS. ALL STEPS WERE DOCUMENTED PER PROCEDURE AND BY TRAINED PERSONNEL. THERE WAS NO EVIDENCE FOUND TO INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION ADDITIONALLY THERE WERE NO SIGNS TO INDICATE THAT A NONCONFORMING DEVICE WAS RELEASED TO THE FIELD.

    Description of Event or Problem · 1

    INITIAL RR 76/48, 9:40 START, 9:50 DEVICE EXPLANT 10:15 RV1 LLD EZ, 10:18 RV2 LLD EZ, 10:20 RV2 GLIDELIGHT 14 EASY WORK TO ATRIUM THEN NO PROGRESSION, 10:25 RV1 GLIDELIGHT 14 EASY WORK TO HIGH SVC THEN NO PROGRESSION, 10:30 RV1 EVN 13 RL N155274 EASY WORK TO APEX THEN 1 CM BEFORE TIP NO PROGRESSION, 10:33 VF 2X 360 J DEFIB NO PRESSURE REANIMATION =>ADRENALIN RR 103/48, 10:38 RV2 EVN 13 RL EASY WORK TO APEX, 10:40 RV2 EXTRACTED IN TOTO, 10:41 CURRENT BLACKOUT OF ANESTHESIA MONITORS => TEE MACHINE RESTARTED, 10:45 RR 42/3, 10:54 HLM STARTED TO STABILIZING PATIENT, 11:00 REANIMATION, 11:12 ECHO PLEURA EFFUSION => THORACOTOMIES, 11:15 HLM RUNNING, 11:20 4 CM HIGH SVC SUPERIOR CUT CLOSED WITH PATCH, 11:30 3 CM CUT AT V. ANONIMA CLOSED WITH PATCH, 11:27 PATIENT STABILIZED, 12:28 LOW FLOW VIA SVC DUE TO SURGICAL LUMEN REDUCTION WITH PATCH, 12:45 VOLUMEN REFILLING WITH CELLSAVER AND ECMO. ONLY 0,6 - 1,2 L VOLUME FILLING POSSIBLE, DUE TO CLOSED SVC. REFILLING WITH T ADAPTER AND VIA V. PULMONALE, V. FEMORAL AND SVC WITHOUT BIGGER SUCCESS, 13:30 DECISION TO STOP THE PUMP => EXITUS.

    Description of Event or Problem · 1

    FOR INVESTIGATION OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805391 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N155274 10827002237473

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death