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

Model Number	700015
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Surgeon was using argon cleaner device, tip broke off of device into patient.Unable to retrieve dislodged tip.No patient complication at the time of surgery.
Additional Manufacturer Narrative
One sample was returned for review.A review of the sample found the lever could advance and actuate the device as intended, but the tip had detached from the control wire, confirming the complaint.A scar (s-2021-0000041) has been assigned to the supplier, roechling medical-lancaster, to determine the root causes and appropriate corrective actions to resolve the issue.The supplier's investigation findings will be reported once the scar has been completed.
Event or Problem Description
Surgeon was using argon cleaner device, tip broke off of device into patient.Unable to retrieve dislodged tip.No patient complication at the time of surgery.

• Brand Name: CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM
• Common Device Name: CLEANER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12425255
• Report Number: 0001625425-2021-01073
• Device Sequence Number: 3714144
• Product Code: KRA
• UDI-Device Identifier: 00886333222315
• UDI-Public: 00886333222315
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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 Expiration Date: 02/22/2024
• Device Model Number: 700015
• Device Catalogue Number: 700015
• Device Lot Number: REF210010/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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