BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEB SL

    MDR report key: 21724474 · Received March 28, 2025

    Report

    Report Number
    2032493-2025-90027
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 17, 2025
    Report Date
    March 28, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429102343
    PMA / PMN Number
    P170032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCE'S ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE IS REPORTED AVAILABLE BUT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DIFFICULT OR NON-DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, WEB SL 8X4 WAS USED FOR THE PROCEDURE BUT THE DEVICE WAS NOT ABLE TO BE DETACHED SO THE DEVICE WAS RETRIEVED. THE PROCEDURE WAS COMPLETE WITH ANOTHER WEB SUCCESSFULLY. THE PATIENT WAS REPORTED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624748 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W2-8-4-MVI 0000610354 00842429102343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other