MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER VAC SYSTEM 18F X 115CM; CATHETER, CONTINUOUS FLUSH

Model Number	70027518
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
An aspiration thrombectomy procedure was performed on a 31-year-old male patient with iliofemoral deep vein thrombosis.Popliteal access with medtronic 20f sentrant introducer, use of aeaner vac system, finding calcification in the proximal segment of the segment to be treated and an acute thrombus of 4 days' evolution the distal segment, liofemoral region.The catheter suffers multiple damages both at the tip and twisting of the other distal body of the aspiration catheter.In the last attempt to aspirate.The trackability dilator fractured.So the procedure could not be completed with 100% success.

• Brand Name: CLEANER VAC SYSTEM 18F X 115CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75758
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 24100958
• Report Number: 0001625425-2026-00926
• Device Sequence Number: 10468986
• Product Code: KRA
• UDI-Device Identifier: 00886333227167
• UDI-Public: (01)00886333227167(17)260815(10)11635348
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K232679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2026
• Device Model Number: 70027518
• Device Lot Number: 11635348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male