BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEB SL

    MDR report key: 18813592 · Received February 29, 2024

    Report

    Report Number
    2032493-2024-00182
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 15, 2024
    Report Date
    February 29, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429102107
    PMA / PMN Number
    P170032
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES 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 WAS NOT 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 MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DIFFICULT OR DELAYED DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THE WEB WAS PREPPED AND TESTED WITH WDC2 PRIOR TO IMPLANT. THE WEB FAILED TO DETACH AFTER INITIAL USE OF WDC2 AND WITH SECOND ATTEMPT. THE VIA17 WAS ADVANCED AND WIRE PULLED/PUSHED RESULTING IN THE WEB DETACHING FROM THE DELIVERY PUSHER. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002478 WEB SL INTRASACCULAR DEVICES OPR MICROVENTION, INC. W5-5-2-MVI 0000364875 00842429102107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown