BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 16811686 · Received April 25, 2023

    Report

    Report Number
    3012931345-2023-00072
    Event Type
    Death
    Date Received
    April 25, 2023
    Date of Event
    February 7, 2023
    Report Date
    June 13, 2023
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    DQY
    PMA / PMN Number
    K131492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EMDR DATA FILE ATTACHMENT: UPDATED B5 EXECUTIVE SUMMARY: UPDATED ALTHOUGH THE DHR (DEVICE HISTORY RECORD) COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER REMAINS UNKNOWN, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS VISUAL TESTING CANNOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THE COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. IT WAS REPORTED DURING A POST-MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY CONDUCTED FOR STRYKER FLOWGATE2® BALLOON GUIDE CATHETER DEVICE #¿S (1) 90485 AND (9) 90495 IN FRANCE, GERMANY, ITALY, SPAIN AND UNITED STATES THAT IN ONE CASE PATIENT DEATH WAS NOTED. THE RISK OF THE ABOVE REPORTED PATIENT HARM IS DOCUMENTED IN THE DFU, AS A POTENTIAL ADVERSE EVENT WHICH CAN OCCUR AS A RESULT OF THESE TYPE OF PROCEDURES. THERE WAS NO INDICATION OF DEVICE MALFUNCTION OR FAILURE, THEREFORE AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION, WILL BE ASSIGNED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 0

    A POST-MARKET CLINICAL FOLLOW-UP (PMCF) ANONYMOUS SURVEY WAS CONDUCTED FOR SUBJECT FLOWGATE2® BALLOON GUIDE CATHETER. THE SURVEY WAS CONDUCTED IN FRANCE. DURING THE SURVEY, A MORTALITY WAS REPORTED TO HAVE OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A POST-MARKET CLINICAL FOLLOW-UP (PMCF) DOUBLE BLIND SURVEY FOR THE SUBJECT FLOWGATE2® BALLOON GUIDE CATHETER, 8F X 95CM, A MORTALITY WAS REPORTED TO HAVE OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539936 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death