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

Model Number	382007045
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without the sample or any visual evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.
Event or Problem Description
During the surgical procedure snare caught on graft and broke off fragment remains in soft tissues out of blood flow isolated by vascular graft.

• Brand Name: ATRIEVE VASCULAR SNARE KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10477215
• Report Number: 1625425-2020-00495
• Device Sequence Number: 13770651
• Product Code: MMX
• UDI-Device Identifier: 20886333004014
• UDI-Public: 20886333004014
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/01/2020

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 Model Number: 382007045
• Device Catalogue Number: 382007045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2020
• 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