BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS VASCULAR ACCESS KIT (MC3)

    MDR report key: 23450030 · Received November 3, 2025

    Report

    Report Number
    3011468686-2025-00107
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 1, 2024
    Report Date
    November 3, 2025
    Manufacturer
    MC3 INC.
    Product Code
    DRE
    PMA / PMN Number
    K182914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 STATED THAT THE OPUS¿ VASCULAR ACCESS KIT DID NOT PERFORM AS EXPECTED FOR ITS ABILITY TO ASSIST IN VESSEL ACCESS/CANNULATION FOR MEDICAL CONDITIONS REQUIRING EXTRACORPOREAL LIFE SUPPORT (ECLS )PROCEDURES WHEN USED IN ADULT PATIENTS IN RELATION TO THE NEEDLE AND DILATOR. THERE WERE PATIENT EFFECTS BECAUSE OF THESE PERFORMANCE ISSUES. IT WAS STATED THAT THE NEEDLE PERFORMANCE ISSUE IMPACTED THE PATIENT AS MULTIPLE STICKS WERE REQUIRED. IT WAS STATED THAT THE DILATOR PERFORMANCE ISSUE IMPACTED THE PATIENT AS A DISSECTION OCCURRED RESULTING IN AORTIC REPLACEMENT. IT WAS STATED THAT THE 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 PEDIATRIC PATIENTS IN RELATION TO THE DILATOR. IT WAS STATED THAT THE DILATOR PERFORMANCE ISSUE IMPACTED THE PATIENT AS A THROUGH AND THROUGH INJURY TO THE BLOOD VESSEL OCCURRED. THREE HEMATOMAS REQUIRING SURGERY AND ONE VESSEL PERFORATIONS OCCURRED. ALL OF THE OCCURRENCES OF THE HEMATOMAS REQUIRING SURGERY WERE SPECIFICALLYRELATED TO THE OPUS¿ VASCULAR ACCESS KIT. IT WAS STATED THAT THE HEMATOMAS OCCURRED AS THE DILATORS WERE NOT SMOOTH ON VESSEL ENTRY CAUSING TEARING. ONE OCCURRENCE OF VESSEL PERFORATION WAS RELATED SPECIFICALLY TO THE OPUS¿ VASCULAR ACCESS KIT. THE VESSEL PERFORATION THAT WAS RELATED TO THE OPUS KIT WAS THE RESULT OF THE DILATORS IN THE KIT CAUSING FAR TOO MUCH FRICTION TO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020144 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| H