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

Model Number	382007030
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
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
Atrieve was used to remove ivc filter and the procedure was successfully completed.Then when the atrieve snare was removed from the patient, there were some adhered substances coiled around the shaft.The adhered substances looks partially fluffy.(b)(6) comment: the customer would like to know what these substances are.Please kindly advice us if these are known phenomenon and/or what possibly these are.Because the procedure was completed without problem, no credit memo is requested.
Additional Manufacturer Narrative
One sample was returned for review, outside of its original packaging.Visual inspection of the sample does show a dark, thin material spindled around approximately 2 inches of the guidewire.The material does not move freely, and crumbles into pieces when stress is applied.As the material was first noticed after the procedure was completed, this issue is likely to have occurred during or after the procedure in the user's environment.The complaint is not confirmed.As no manufacturing defect has been detected, no corrective action will be taken at this time.
Event or Problem Description
Atrieve was used to remove ivc filter and the procedure was successfully completed.Then when the atrieve snare was removed from the patient, there were some adhered substances coiled around the shaft.The adhered substances looks partially fluffy.Sugan comment: the customer would like to know what these substances are.Please kindly advice us if these are known phenomenon and/or what possibly these are.Because the procedure was completed without problem, no credit memo is requested.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Common Device Name: ATRIEVE
• 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: 14198626
• Report Number: 0001625425-2022-00992
• Device Sequence Number: 12073667
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 08/08/2023
• Device Model Number: 382007030
• Device Catalogue Number: 382007030
• Device Lot Number: 11228285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/21/2022
• 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
• Patient Sex: Unknown