MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 7FR

Model Number	382007030
Medical Device Problem Codes	No Apparent Adverse Event (3189); Activation Failure (3270)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
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
The filter did not open after release(cc# (b)(4), and was taken out with our three-ring trap, and additional equipment needed to be compensated.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.After third notification, sample was not returned to argon.The complaint was closed.No corrective required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
The filter did not open after release (cc#: 14855), and was taken out with our three-ring trap, and additional equipment needed to be compensated.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Common Device Name: ATRIEVE VASCULAR SNARE KIT
• 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: 16454398
• Report Number: 0001625425-2023-00976
• Device Sequence Number: 17611259
• Product Code: MMX
• UDI-Device Identifier: 20886333003994
• UDI-Public: 20886333003994
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021606
• 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
• Report Date (Section B): 04/03/2023

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: 07/13/2026
• Device Model Number: 382007030
• Device Catalogue Number: 382007030
• Device Lot Number: 11374942
• Was Device Available for Evaluation?: No
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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: Required Intervention; Other
• Patient Sex: Unknown