MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM; CLEANER 15

Model Number	700015
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer said that this was a routine fistula de-clot he said that nothing was out of the ordinary.During the process of de-clotting the fistula using the cleaner the tip of the device came off.They were not able to retrieve the piece from the patient.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.A review of the returned product from the customer was performed.Visual inspection of the sample returned from the customer found minor body fluid on the device and polymer tip breakage from the sinuous wire segment (thrombus maceration).Functional test of the device returned from the customer confirmed that turn on/off and sliding lever backward/forward of the device worked without issue.The rotating wire was rotating normally, but there was a polymer tip breakage from the sinuous wire segment, and the complaint was confirmed.A scar# (b)(4) has been issued to notify the supplier (b)(4) that an investigation is necessary.Per the supplier's investigation, they will take the necessary corrective measures.
Event or Problem Description
The customer said that this was a routine fistula de-clot he said that nothing was out of the ordinary.During the process of de-clotting the fistula using the cleaner the tip of the device came off.They were not able to retrieve the piece from the patient.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM
• Common Device Name: CLEANER 15
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1455 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18292535
• Report Number: 0001625425-2023-01254
• Device Sequence Number: 6696625
• Product Code: KRA
• UDI-Device Identifier: 00886333222315
• UDI-Public: (01)00886333222315(17)260531(10)230043/1
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2024

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: 05/31/2026
• Device Model Number: 700015
• Device Lot Number: 230043/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 08/31/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/20/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: Other
• Patient Sex: Unknown