BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS VASCULAR ACCESS KIT (MC3)

    MDR report key: 23322760 · Received October 17, 2025

    Report

    Report Number
    3011468686-2025-00086
    Event Type
    Injury
    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
    Adverse Event
    Yes
    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 HEMATOMAS REQUIRING SURGERY AND TISSUE DAMAGE OCCURRED. THE ONE HEMATOMA REQUIRING SURGERY WAS RELATED TO PRE-EXISTING CONDITION OR CO-MORBIDITY AND THE OTHER OCCURRENCE WAS SPECIFICALLY RELATED TO OPUS¿ VASCULAR ACCESS KIT. THE TISSUE DAMAGE THAT OCCURRED ON ENTRY WAS SPECIFICALLY RELATED TO THE OPUS¿ VASCULAR ACCESS KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827673 OPUS VASCULAR ACCESS KIT (MC3) DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZAT DRE MC3 INC. 21030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention