BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 16875814 · Received May 5, 2023

    Report

    Report Number
    3012931345-2023-00080
    Event Type
    Malfunction
    Date Received
    May 5, 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
    K153729
    Product Problem
    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 WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT 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 THE TWO DEFECTS BALLOON LEAKED DURING USE AND BALLOON CATHETER KINKED/BENT WERE NOTED. THE PATIENTS' OUTCOME WAS UNKNOWN. THE DEVICE WAS NOT RETURNED. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE, A CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 0

    H3 : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 0

    POST-MARKET CLINICAL FOLLOW-UP (PMCF) ANONYMOUS SURVEY WAS CONDUCTED FOR SUBJECT FLOWGATE2® BALLOON GUIDE CATHETER. THE SURVEY WAS CONDUCTED IN GERMANY. DURING THE SURVEY, A PRODUCT MALFUNCTION OF LEAKING/ KINKING WERE REPORTED TO HAVE OCCURRED AS PER THE RESPONSES RECEIVED. NO OTHER INFORMATION IS AVAILABLE ABOUT THE EVENTS REPORTED IN THE SURVEY.

    Description of Event or Problem · 0

    POST-MARKET CLINICAL FOLLOW-UP (PMCF) ANONYMOUS SURVEY WAS CONDUCTED FOR SUBJECT FLOWGATE2® BALLOON GUIDE CATHETER. THE SURVEY WAS CONDUCTED IN FRANCE, GERMANY, ITALY, SPAIN AND UNITED STATES. DURING THE SURVEY, A PRODUCT MALFUNCTION OF LEAKING/ KINKING WERE REPORTED TO HAVE OCCURRED AS PER THE RESPONSES RECEIVED. NO OTHER INFORMATION IS AVAILABLE ABOUT THE EVENTS REPORTED IN THE SURVEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814091 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown