MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER VAC ASPIRATION CATH&HANDPIECE 18FX115CM; PERIPHERAL MECHANICAL THROMBECTOMY

Model Number	70020018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter started to accordion during the 4th pass.After getting in position for the 6th pass the dilator snapped at the proximal portion if the shapable segment.The dilator was used to advance the catheter over the wire each time we positioned the catheter for use.The catheter would not advance through the popliteal vein as it lied with in the ligament tunnel and required additional support.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
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.One used one dilator and one catheter was returned to argon from the customer.A visual inspection was performed on the returned product.For this unit, there was confirmed accordioned regions along the catheter body indicating high compressive/tension loading of the catheter during advancement and withdraw passes.From our vc, our catheter was used for approximately 7 passes in total before the dilator failed at the hemostasis hub.Before the failure, it was noted by the scrub technician that the removal force of the dilator was higher than expected based on previous passes.The reduced diameter section was elongated and eventually fractured during use.The physician was able to cut the catheter below the hemostasis hub and remove all components of the cleaner vac catheter and dilator.The dilator portion left within the hub was easily removed during the investigation with hemostats.The distal end of the dilator was stuck within an additional portion of the catheter body.This portion of the catheter was carefully cut without damaging the dilator tip to expose the dilator.It was observed that the coil appeared to be partially embedded in the dilator tip.It was noted that the there were competitor devices used on the same patient and those devices also experience accordion damage.Manufacturing engineering attempted to recreate, but was not successful.It is speculated that the issue occurred during an event within the user's environment.Since the most likely cause of the issue does not point to a manufacturing issue, no further action will be pursued at this time.However, argon will continue to monitor for recurrence.Additional information provided in h.3., h.6.And h.11.

• Brand Name: CLEANER VAC ASPIRATION CATH&HANDPIECE 18FX115CM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY
• 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: 23042306
• Report Number: 0001625425-2025-01079
• Device Sequence Number: 9937113
• Product Code: QEW
• UDI-Device Identifier: 00886333227174
• UDI-Public: (01)00886333227174(17)060402(10)11616466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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 Expiration Date: 04/02/2026
• Device Model Number: 70020018
• Device Lot Number: 11616466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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
• Patient Sex: Unknown