BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTER C

    MDR report key: 22129135 · Received June 2, 2025

    Report

    Report Number
    2032493-2025-90219
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 2, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    UDI-DI
    00842429101988
    PMA / PMN Number
    K110741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 BALLOON RUPTURE POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT'S LEFT INTERNAL CAROTID ARTERY WAS 3.5MM DISTAL AND 4.0MM PROXIMAL, AND A 4.0 * 15 BALLOON WAS SELECTED. HOWEVER, THE BALLOON WAS DAMAGED AT THE BEGINNING OF PRESSURIZATION. THE DEVICE WAS REMOVED AND REPLACED WITH THE SAME TYPE OF BALLOON, AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401838 SCEPTER C CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN MICROVENTION, INC. BC0415C-ID-CN 0000429304 00842429101988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other