BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDI CATHETER ENFIT 12FR/125 CM, 5PCS

    MDR report key: 22539354 · Received July 18, 2025

    Report

    Report Number
    8010042-2025-0001122
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 18, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710004668
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION COLLECTED TO DATE, IT HAS BEEN CLARIFIED THAT THE EDI CATHETER WAS INSERTED AND IN USE FROM JUNE 23, 2025 UNTIL THE EVENT DATE JULY 2, 2025. THE PATIENT HAD INDICATIONS OF SWALLOWING DIFFICULTIES AND EXPERIENCED EPISODES OF VOMITING, ONE OF WHICH A FIVE CM PIECE OF THE EDI CATHETER WAS FOUND IN THE GASTRIC CONTENT. THE EDI CATHETER WAS REMOVED, AND FOLLOW-UP CHEST X-RAY SHOWED A RESIDUAL CATHETER FRAGMENT IN THE GASTRIC CAVITY. THERE WAS NO INDICATION FOR ENDOSCOPIC REMOVAL. THE FINAL PATIENT OUTCOME WAS NO HARM. THE SUBJECTED EDI CATHETER WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR TECHNICAL ANALYSIS. FURTHER INFORMATION REGARDING THE USAGE WAS REQUESTED FROM THE HEALTHCARE FACILITY BUT NO RESPONSE WAS RECEIVED. THERE HAVE BEEN NO REPORTS OF DIFFICULTIES INSERTING THE EDI CATHETER OR ISSUES WITH NAVA VENTILATION DURING THE TIME THE EDI CATHETER WAS IN USE. PHOTOS OF THE EDI CATHETER WAS PROVIDED. THE DISTAL TIP MEASURING APPROXIMATELY 5 CM WAS BROKEN OFF AND DISCOLORED, WITHOUT VISIBLE SWELLING. THE REMAINING PART OF THE EDI CATHETER WAS ALSO DISCOLORED WITHOUT SWELLING. THE EDI CATHETER WAS USED FOR NINE DAYS, WHICH EXCEEDED THE RECOMMENDED MAXIMUM USAGE DURATION OF FIVE DAYS AS OUTLINED IN THE USER'S MANUAL. SINCE THE BATCH NUMBER WAS NOT PROVIDED, A CHECK OF THE MATERIAL PARAMETERS FROM MANUFACTURING RECORDS FOR THE SUBJECTED EDI CATHETER COULD NOT BE PERFORMED. IN CONCLUSION, THERE ARE NO INDICATIONS OF AN EDI CATHETER MALFUNCTION. THE CAUSE OF BREAKAGE OF THE EDI CATHETER HAS NOT BEEN CONCLUSIVELY DETERMINED BUT A COMBINATION OF EFFECTS FROM THE SURROUNDING CHEMICAL AND BIOLOGICAL ENVIRONMENT IN THE STOMACH AND THE EXTENDED DURATION OF USE COULD HAVE CAUSED OR CONTRIBUTED TO THE BREAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING NEURALLY CONTROLLED NAVA TREATMENT WHERE A NASO-GASTRIC EDI CATHETER IS USED FOR TRANSFER OF ELECTRICAL ACTIVITY OF THE DIAPHRAGM (EDI SIGNAL) TO THE VENTILATOR SYSTEM. THE PATIENT SUDDENLY HAD EPISODES OF VOMITING WHERE A PIECE OF THE EDI CATHETER WAS FOUND IN THE GASTRIC CONTENT. THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND ANXIETY. THE EDI CATHETER WAS REMOVED, AND FOLLOW-UP CHEST X-RAY SHOWED A RESIDUAL CATHETER PIECE IN THE GASTRIC CAVITY. THERE IS NO INDICATION FOR ENDOSCOPIC REMOVAL. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF # (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749165 EDI CATHETER ENFIT 12FR/125 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6883903 UNKNOWN 17325710004668

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Life Threatening