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

Model Number	700015
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
He is treatment for dvt at upper iliac vein.He has enough experiences for cleaner and he followed ifu procedure step.The wire tip was apart when cleaner is working so he took ct and the tip was found at inferior epigastric vein so he decided it is hard to remove and the tip was left behind due to low risk to the patient.He informed a patient about it and he will continue to monitor the patient¿s condition.
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
He is treatment for dvt at upper iliac vein.He has enough experiences for cleaner and he followed ifu procedure step.The wire tip was apart when cleaner is working so he took ct and the tip was found at inferior epigastric vein so he decided it is hard to remove and the tip was left behind due to low risk to the patient.He informed a patient about it and he will continue to monitor the patient¿s condition.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of returned product from the customer was performed, visually inspect the device found polymer tip was broken from the sinuous wire segment, functionally test the device, power turn on/off normally and control wire rotating without any issue and the complaint was confirmed.A scar# 00056 has been issued to notify the supplier roechling medical that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.
Event or Problem Description
He is treatment for dvt at upper iliac vein.He has enough experiences for cleaner and he followed ifu procedure step.The wire tip was apart when cleaner is working so he took ct and the tip was found at inferior epigastric vein so he decided it is hard to remove and the tip was left behind due to low risk to the patient.He informed a patient about it and he will continue to monitor the patient¿s condition.

• Brand Name: CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM
• Common Device Name: CLEANER15
• 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: 14841950
• Report Number: 0001625425-2022-01038
• Device Sequence Number: 12073634
• Product Code: KRA
• UDI-Device Identifier: 00886333222315
• UDI-Public: 00886333222315
• 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: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2022

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: 08/08/2024
• Device Model Number: 700015
• Device Catalogue Number: 700015
• Device Lot Number: REF210044/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 09/06/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/04/2022; 09/06/2022
• 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; Required Intervention
• Patient Sex: Unknown