MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM; DILATOR, VESSEL FOR PERCUTANEOUS CATH

Model Number	MIS-7F07
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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.

• Brand Name: CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM
• Common Device Name: DILATOR, VESSEL FOR PERCUTANEOUS CATH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22400475
• Report Number: 0001625425-2025-01052
• Device Sequence Number: 15596840
• Product Code: DRE
• UDI-Device Identifier: 00886333227532
• UDI-Public: 00886333227532
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MIS-7F07
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown