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

Model Number 352506070E

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2021

Event Type  malfunction  

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 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
• Type of Device: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: gedaa hassan ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12636994
• MDR Text Key: 279017542
• Report Number: 0001625425-2021-01097
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217519
• UDI-Public: 00886333217519
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11378921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other