BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON ELITE CANNULA & CATHETER

    MDR report key: 24544450 · Received March 9, 2026

    Report

    Report Number
    8010762-2026-0000106
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 21, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04058863133843
    PMA / PMN Number
    K130639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CANNULATION PROCEDURE TO START EXTRACORPOREAL OXYGENATION SUPPORT IN VENO-VENOUS ECMO CONFIGURATION, PERFORMED ON (B)(6) 2026, DURING THE INTRODUCTION OF THE 0.038" METAL GUIDE THROUGH THE WHITE INTRODUCER OF THE AVALONE ELITE 31FR CANNULA, IT WAS FOUND IMPOSSIBLE TO PROGRESS BEYOND APPROXIMATELY 4 CM FROM THE TIP OF THE DEVICE. THE GUIDE ENCOUNTERED A CLEAR MECHANICAL "STOP", WHICH COULD NOT BE OVERCOME WITH STANDARD MANEUVERS AND WITHOUT THE APPLICATION OF EXCESSIVE FORCE. NO FORCED ATTEMPTS WERE MADE TO AVOID POSSIBLE DAMAGE TO THE DEVICE OR RISKS FOR THE PATIENT. FOLLOWING THE CRITICALITY, IT WAS DECIDED NOT TO USE THE CANNULA IN QUESTION AND TO PROCEED WITH AN ALTERNATIVE IMPLANT USING: CRESCENT JUGULAR DUAL LUMEN CATHETER SIZE: 32FR. THE PROCEDURE WAS THEREFORE COMPLETED WITHOUT FURTHER TECHNICAL CRITICALITIES. IN ORDER TO EXCLUDE A PROBLEM RELATED TO THE REVAS KIT GUIDE, A NEW TEST WAS CARRIED OUT USING A SECOND 0.038" GUIDE (AB MEDICA, REF K2AGFJ3381801A). THE SAME CRITICAL ISSUE OCCURRED IN THIS CASE AS WELL: THE GUIDEWIRE STOPPED APPROXIMATELY 4 CM FROM THE TIP OF THE INTRODUCER, MAKING PROGRESSION IMPOSSIBLE. THE REPRODUCIBILITY OF THE PROBLEM WITH TWO DIFFERENT GUIDES SUGGESTS A POSSIBLE STRUCTURAL ANOMALY IN THE INTRODUCER LUMEN (E.G., NARROWING, PARTIAL OCCLUSION, OR MANUFACTURING DEFECT). NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE WAS DETECTED DURING INSERT (AND THE GUIDEWIRE WAS ALREADY INSERTED TO PATIENT), AND A REPLACEMENT WAS REQUIRED, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301751 AVALON ELITE CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH 10031-CE 471288 04058863133843

    Patients

    Seq Age Sex Outcome Treatment
    1