BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM

    MDR report key: 22400475 · Received July 3, 2025

    Report

    Report Number
    0001625425-2025-01052
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    May 21, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DRE
    UDI-DI
    00886333227532
    PMA / PMN Number
    K780126
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT CANNOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO SAMPLE WAS RETURNED TO ARGON FROM THE CUSTOMER; HOWEVER, IMAGES WERE PROVIDED BY THE CUSTOMER. THE IMAGES SHOWS THE INTRODUCER WAS IN TWO PARTS. THE INTRODUCER TUBING LOOKS TO HAVE BEEN MELTED APART BY A HEATING ELEMENT. THIS LIKELY HAPPENED DURING THE PROCEDURE IN THE USER'S ENVIRONMENT. SINCE THE ISSUE MOST LIKELY WAS CAUSED BY AN EVENT WITHIN THE USER'S ENVIRONMENT, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION PROVIDED IN H6 AND H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE LEFT GREAT SAPHENOUS VEIN IN A PATIENT, SEVERAL ISSUES OCCURRED. THE VEIN WAS ACCESSED AT THE PROXIMAL THIGH AROUND 12 CM FROM THE SAPHENOFEMORAL JUNCTION (SFJ), AND THE CLOSUREFAST 7F 100CM CATHETER WAS POSITIONED 2.7 CM FROM THE SFJ. TUMESCENT INFILTRATION, LOCAL ANESTHESIA AND COMPRESSION WERE UTILIZED. DURING THE FIRST TREATMENT LOCATED AT THE #11 ON THE CATHETER, AN ADVISORY MESSAGE OF "LOW TEMPERATURE, HIGH POWER ADJUST COMPRESSION" APPEARED WITH 11 SECONDS LEFT, AND THE TREATMENT WATTAGE DID NOT DROP BELOW 20 WATTS WITHIN THE FIRST 10 SECONDS. ADDITIONAL HAND COMPRESSION WAS APPLIED, AND THE MESSAGE RESOLVED. THE SAME WATTAGE ISSUE OCCURRED DURING THE SECOND TREATMENT. THE TEAM WAS INFORMED, AND A THIRD TREATMENT WAS PERFORMED WITH ULTRASOUND PROBE COMPRESSION AND FINGER COMPRESSION, AFTER WHICH PARAMETERS WERE ESTABLISHED. A FOURTH TREATMENT WAS PERFORMED TO ENSURE ADEQUATE TREATMENT AT THE SAPHENOFEMORAL JUNCTION. SUBSEQUENT TREATMENTS AT THE #7 MARK ON THE CATHETER MET ALL PARAMETERS WITHOUT FURTHER ADVISORY MESSAGES. A LOT OF RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE MICRO INTRODUCER 7F 7CM SHEATH. THE NURSE PRACTITIONER TUGGED MORE AND PART OF THE SHAFT OF THE SHEATH DETACHED IN VIVO AND SPLIT IN HALF UPON REMOVAL. THE CATHETER AND REMAINING SHEATH COMPONENTS WERE REMOVED. ULTRASOUND IMAGING WAS CONDUCTED TO INSPECT FOR ANY RETAINED SHEATH FRAGMENTS, AND IT WAS CONFIRMED THAT NO SOLID OBJECTS REMAINED IN THE DISTAL PART OF THE GREAT SAPHENOUS VEIN OR SOFT TISSUE. A KINK IN THE COIL OF THE CATHETER WAS NOTED POST-PROCEDURE. ANATOMICAL IRREGULARITY WAS PRESENT, WITH THE GREAT SAPHENOUS VEIN DEPTH MEASURED AT 3 CM FROM THE SKIN AND 4 CM AT THE SAPHENOFEMORAL JUNCTION. THE VEIN WAS CONFIRMED TO BE CLOSED AT THE END OF THE PROCEDURE, AND ALL TREATED SEGMENTS WERE COMPLETED BEFORE THE EVENT OCCURRED. NO INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128431 CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM DILATOR, VESSEL FOR PERCUTANEOUS CATH DRE ARGON MEDICAL DEVICES MIS-7F07 UNK 00886333227532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown