MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM

Model Number	700009XT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that during a mechanical thrombectomy procedure, the s-wire of cleaner device broke off in patient and had to be snared out.There was no patient injury.
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 sample was returned to argon from the customer.A visual inspection was performed on the retuned sample.The visual inspection determined that the sinusoidal wire was broken off from the cleaner device.It is likely that excessive force was applied to the device during manipulation.Since the most probable cause is related to an event within the user's environment, no corrective action will be pursued at this time.However, argon will continue to monitor for recurrence.

• Brand Name: CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM
• Common Device Name: CLEANER XT
• 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: 19726595
• Report Number: 0001625425-2024-01065
• Device Sequence Number: 12844006
• Product Code: KRA
• UDI-Device Identifier: 00886333222308
• UDI-Public: (01)00886333222308(17)270123(10)REF240004/1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2024

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 Model Number: 700009XT
• Device Lot Number: REF240004/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown