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

Model Number	352506070E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer's response, the sample was not available for return and evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.However, multiple complaints were received regarding this issue, and capa (b)(4) was initiated to investigate the root cause of the radiopaque marker band detachment and correct it.
Event or Problem Description
During the procedure, under fluoroscopy, the doctor noticed that the radiopaque marker at the end of the introducer sheath was missing.The 2 markers on the dilator were visible, and the doctor was familiar with the option, that he noticed the 3rd marker on the end of the sheath was not there.The sheath was removed and another option filter was used.

• 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
• MDR Report Key: 12636994
• Report Number: 0001625425-2021-01097
• Device Sequence Number: 3750954
• Product Code: DTK
• UDI-Device Identifier: 00886333217519
• UDI-Public: 00886333217519
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133243
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 07/29/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11378921
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/14/2021
• 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