BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPUS VASCULAR ACCESS KIT (MC3)

    MDR report key: 23322686 · Received October 17, 2025

    Report

    Report Number
    3011468686-2025-00085
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    October 1, 2024
    Report Date
    October 17, 2025
    Manufacturer
    MC3 INC.
    Product Code
    DRE
    PMA / PMN Number
    K182914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THROUGH A POST MARKET FOLLOW-UP (PMCF) SURVEY, FOR OPUS¿ VASCULAR ACCESS KIT, THAT THE USER REPORTED THAT OPUS¿ VASCULAR ACCESS KIT DID NOT PERFORM AS EXPECTED FOR ITS ABILITY TO ASSIST IN VESSEL ACCESS/CANNULATION FOR MEDICAL CONDITIONS REQUIRING ECLS PROCEDURES WHEN USED IN ADULT PATIENTS IN RELATION TO GUIDEWIRE AND DILATOR. THE DILATOR PERFORMANCE ISSUE RESULTED IN DIFFICULTY CANNULATING AND THIS IMPACTED PATIENTS. THE GUIDEWIRE PERFORMANCE ISSUES DID NOT RESULT IN ANY PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323532 OPUS VASCULAR ACCESS KIT (MC3) DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZAT DRE MC3 INC. 21030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown