BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI2

    MDR report key: 9836914 · Received March 16, 2020

    Report

    Report Number
    2126666-2020-00024
    Event Type
    Death
    Date Received
    March 16, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 13, 2020
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    UDI-DI
    08714729887621
    PMA / PMN Number
    K151244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. REVIEW OF THE DIRECTIONS FOR USE LISTS THE REPORTED EVENT AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. SHOULD ADDITIONAL INFORMATION BE PROVIDED OR PRODUCT BE RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT WAS REPORTED THAT: DURING A TAVI PROCEDURE AND BEFORE INTRODUCING THE ACURATE NEO DEVICE, PATIENT STARTED TO COMPLAIN OF HAVING CHEST PAIN. PATIENT BEGAN TO FIBRILLATE AND PRESSURES DROPPED. PATIENT WAS UNABLE TO BE REVIVED. ONLY MATERIAL OF BOSTON DURING THE PROCEDURE WAS: SAFARIXS, ISLEEVE 14F. WAS IVUS USED? NO. WAS A GENERATOR INVOLVED? NO. PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE UNKNOWN. ADDITIONAL INFORMATION RECEIVED: WERE THERE ANY ISSUES WITH THE ISLEEVE OR SAFARI2? NO. WAS ANY VESSEL OR CARDIAC DAMAGE NOTED (PERFORATION, DISSECTION, ETC?): NO. WAS THE FIBRILLATION ATRIAL OR VENTRICULAR? NA. WHAT ACTIONS WERE TAKEN (SURGERY, CPR, ETC)? CPR. WHAT IS THE DOCUMENTED CAUSE OF DEATH? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298335 PREFORM GUIDEWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL H74939406XS1 11160174 08714729887621

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death