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

Model Number	382007045
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
During the use the tip of the atrieve¿ vascular snare was left in the patient's body and the doctor immediately moving the patient to the operating room to remove the tip.
Event or Problem Description
During the use the tip of the atrieve¿ vascular snare was left in the patient's body and the doctor immediately moving the patient to the operating room to remove the tip.Unfortunately the product won't be able to return and we also cannot provide other evidences for you.
Additional Manufacturer Narrative
A review of the returned sample found the loops were broken off from the shaft.The silver lining on the loops were damaged, pulled to the middle, and entangled in bioburden.It is likely that the snare was caught on something upon retrieval and excessive force was used during manipulation which could have caused the breakage.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 7FR
• Common Device Name: ATRIEVE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12339450
• Report Number: 0001625425-2021-01068
• Device Sequence Number: 3887663
• Product Code: MMX
• UDI-Device Identifier: 20886333004014
• UDI-Public: 20886333004014
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2024
• Device Model Number: 382007045
• Device Catalogue Number: 382007045
• Device Lot Number: 11273951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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