MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER

Model Number	352506100E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Distal radiopaque band came off the dilator while getting inserted into the body, and the radiopaque band traveled into the right lungs¿.
Event or Problem Description
Distal radiopaque band came off the dilator while getting inserted into the body, and the radiopaque band traveled into the right lungs¿ ¿ see photos.
Additional Manufacturer Narrative
The device was not returned.Photos provided by the customer showed the distal side of the dilator marker missing, and the complaint was confirmed.Capa (c-2021-035) shall address a customer complaint regarding the option elite dilator's platinum marker band detaching during a procedure.The capa will investigate why the platinum marker did not stay secured in position and implement a solution to resolve the issue.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the photo, provided by the customer, found one of two marker, distal side of the dilator marker is missing, and the complaint was confirmed.Capa (c-2021-035) shall address a customer complaint regarding the option elite dilator's platinum marker band detaching during a procedure.The capa will investigate why the platinum marker did not stay secured in position and implement a solution to resolve the issue.
Event or Problem Description
Distal radiopaque band came off the dilator while getting inserted into the body, and the radiopaque band traveled into the right lungs¿ ¿ see photos.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.Quality engineer and complaint analyst reviewed the sample returned from the customer.Customer returned dilator and found one of two marker band was missing (distal side of the dilator) and the complaint was confirmed.Capa (c-2021-035) shall address a customer complaint regarding the option elite dilator's platinum marker band detaching during a procedure.The capa will investigate why the platinum marker did not stay secured in position and implement a solution to resolve the issue.
Event or Problem Description
Distal radiopaque band came off the dilator while getting inserted into the body, and the radiopaque band traveled into the right lungs¿ ¿ see photos.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: OPTION ELITE
• 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: 12425404
• Report Number: 0001625425-2021-01074
• Device Sequence Number: 3714145
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2022

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: 01/15/2024
• Device Model Number: 352506100E
• Device Catalogue Number: 352506100E
• Device Lot Number: 11347150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 08/18/2021; 08/18/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/29/2021; 01/28/2022; 02/21/2022
• 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; Required Intervention
• Patient Sex: Unknown