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

Model Number	700009XT
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.
Event or Problem Description
When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the distal end of the sinusoidal wire was misshapen, meaning instead of going straight after the last wave, it followed the path of the wave.Thus confirming the complaint.The samples are being sent back to the supplier for further investigation.A scar# s-2020-00005 has been issued to notify the supplier roechling medical lancaster that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the distal end of the sinusoidal wire was misshapen, meaning instead of going straight after the last wave, it followed the path of the wave.Thus confirming the complaint.The samples are being sent back to the supplier for further investigation.A scar has been issued to notify the supplier roechling medical lancaster that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.
Event or Problem Description
When deploying the cleaner, the sinusoidal wire bent at the tip.The device was also difficult to remove after issue.

• 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: 13251527
• Report Number: 0001625425-2022-00926
• Device Sequence Number: 11854469
• Product Code: KRA
• UDI-Device Identifier: 00886333222308
• UDI-Public: 00886333222308
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2022

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 Expiration Date: 06/21/2024
• Device Model Number: 700009XT
• Device Catalogue Number: 700009XT
• Device Lot Number: REF210029/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 12/28/2021
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/07/2022; 02/14/2022
• 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