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)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Tip broke off in a patient during use.
Additional Manufacturer Narrative
The sample has not been returned for review after three notifications to the customer.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, determining root cause and corrective action is not possible and the complaint was not confirmed.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
Tip broke off in a patient during use.

• 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
• MDR Report Key: 12492574
• Report Number: 0001625425-2021-01083
• Device Sequence Number: 4460045
• Product Code: KRA
• UDI-Device Identifier: 00886333222308
• UDI-Public: 00886333222308
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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 Expiration Date: 06/21/2024
• Device Model Number: 700009XT
• Device Catalogue Number: 700009XT
• Device Lot Number: REF210029/1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/29/2021
• 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