BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB LOW PROFILE SL-USA W4-6-5FOR US

    MDR report key: 9091608 · Received September 19, 2019

    Report

    Report Number
    2032493-2019-00228
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 20, 2019
    Report Date
    August 20, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006112
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED. THE ROOT CAUSE CANNOT BE DETERMINED. A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES RUPTURE AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THIS DEVICE. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED DURING THE SAME PROCEDURE REFERENCED IN MFR. REPORT # 2032493-2019-00226.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A MIDDLE CEREBRAL ARTERY ANEURYSM, THE MICROCATHETER RUPTURED THE DOME OF THE ANEURYSM. A WEB DEVICE WAS BEING ADVANCED THROUGH THE MICROCATHETER AT THE TIME. THE PATIENT WAS TREATED WITH BALLOON REMODELING AND SIX EMBOLIZATION COILS. AFTER EXTUBATION, THE PATIENT WAS REPORTED TO HAVE NO COGNITIVE IMPAIRMENT AND WAS MOVING BOTH SIDES OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883087 WEB LOW PROFILE SL-USA W4-6-5FOR US WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM, PRODUCT OPR SEQUENT MEDICAL, INC FGA25060-050 19032908 00854111006112

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R