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

Model Number	382007030
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.As of the date of this report, it has not yet been returned.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Atrieve snare being used for filter removal.One of the snare loops that is wrapped with the thin wire around the loop looked to break or begin to unwind.Doctor not sure if he caught the loop on a sharp area of the filter when pulling to retrieve.Team able to retrieve filter as well as the small piece that was frayed off through the sheath.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11520662
• Report Number: 1625425-2021-00876
• Device Sequence Number: 19732783
• Product Code: MMX
• UDI-Device Identifier: 20886333003994
• UDI-Public: 20886333003994
• Combination Product (Y/N): N
• Initial Reporter State: MD
• PMA/510(K) Number: K021606
• 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): 03/18/2021

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: 12/14/2025
• Device Model Number: 382007030
• Device Catalogue Number: 382007030
• Device Lot Number: 11343855
• 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: 03/18/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1