MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM; CATHETER, CONTINUOUS FLUSH

Model Number	700009XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.No samples were returned from the customer for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, determining root cause or corrective action is not possible.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.Additional information provided in h.6.And h.11.
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
The tip of the cleanerxt is broke during the procedure.Faulty item was disposed by end user as it was contaminated.

• Brand Name: CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 21400030
• Report Number: 0001625425-2025-00946
• Device Sequence Number: 15798292
• Product Code: KRA
• UDI-Device Identifier: 00886333222308
• UDI-Public: 00886333222308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141617
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 700009XT
• Device Lot Number: REF240070/1
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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