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	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to product experience report, the affected product was not available for return.If there are additional information available in future, a follow-up will be submitted.
Event or Problem Description
Device was in the body but did not turn on.No harm was done to patient.
Event or Problem Description
Device was in the body but did not turn on.No harm was done to patient.
Additional Manufacturer Narrative
One opened device was returned for evaluation.Visual inspection found no damage to the product.Functional testing found that the device did not activate when the button was pushed.The complaint was confirmed.The device was disassembled and both batteries were putting out only 2.4 volts.The batteries should be putting out 9 volts each.Dead batteries was the cause of the issue.Since the ifu states to test the device before use and if it doesn't activate do not use the device.As such, no corrective action was taken.

• Brand Name: CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 65CM
• Common Device Name: CLEANER
• 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: 12870775
• Report Number: 0001625425-2021-01133
• Device Sequence Number: 11203999
• Product Code: KRA
• UDI-Device Identifier: 00886333222308
• UDI-Public: 00886333222308
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 21002911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/16/2021
• 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