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

Model Number	700009XT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The wire did not rotate when he was pressing the button for rotating to treat avg thrombus.He took it out from avg and found the wire was bent wrong way.He used other cleaner and finished the procedure.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
The wire did not rotate when he was pressing the button for rotating to treat avg thrombus.He took it out from avg and found the wire was bent wrong way.He used other cleaner and finished the procedure.
Additional Manufacturer Narrative
A review of the dhr and inspection records was not conducted since a lot number was not provided.One opened device was returned for review.Visual inspection confirmed signs of use and it was found that the sheath and wire were kinked at the proximal end.Functionally, the device did actuate when the button was pressed, therefore, this complaint could not be confirmed.The sheath slide lever was moved to expel the wire and the wire was observed to be kinked.The silicone tip was present with no damage.The most probable cause for the damage to the product was most likely the result of an event within the user environment.Possibly, during the procedure an excessive force was utilized resulting in the damage to the wire and sheath which may have also contributed to the reported issue.Since the reported issue was most likely the result of an event within the user environment and not a manufacturing error, no corrective action will be taken.

• Brand Name: CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM
• Common Device Name: CLEANER XT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14111566
• Report Number: 0001625425-2022-00978
• Device Sequence Number: 11944175
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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 Catalogue Number: 700009XT
• Device Lot Number: 210007/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown