MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 135CM

Model Number	700115
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.A follow-up report will be provided once the sample has been received and reviewed.
Event or Problem Description
Physician was using cleaner 15 with the penumbra lightning aspiration system with the indigo cat 12.They were working in the left femoral vein, the indigo catheter was below the cleaner device and both devices were activated and working simultaneously.The physician reported pulling back on the cleaner device and felt like it got caught in a valve with a lot of thrombus present.She reported hearing an odd sound from the device and that the device looked different.They removed the device and noticed that the atraumatic tip was no longer attached to the wire.They used multiple devices and spent about an hour trying to retrieve the tip without success.Upon reviewing ct imaging (pictures attached), the atraumatic tip of the cleaner is currently outside of femoral vein between the femoral artery and vein.The patient has not experienced any adverse effects, as of the date of this report.The plan is to continue to monitor the patient.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 135CM
• Common Device Name: CLEANER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11724782
• Report Number: 1625425-2021-00912
• Device Sequence Number: 19795018
• Product Code: QEW
• UDI-Device Identifier: 00886333222339
• UDI-Public: 00886333222339
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K141617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 700115
• Device Catalogue Number: 700115
• Device Lot Number: 200030/1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1