MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE IVC FILTER

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Event Description

The hemostatic valve on the 5 f sheath was not secure and disconnected as they were injecting contrast at the end of the procedure.

Manufacturer Narrative

The sample is indicated as being returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.

Event Description

The hemostatic valve on the 5 f sheath was not secure and disconnected as they were injecting contrast at the end of the procedure.

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 delivery catheter sheath.Returned product was visually inspected to confirm that valve cap was separated or detached from the valve, foam washer and hemo statics valve was present in the valve.Not found any indication glue properly apply on the valve cap during the assembly and the complaint was confirmed.The most probable root cause of this issue is manufacture error.During the assembly process, the operator is supposed to have the gluing tip pressed against the cap at an angle so as not to block the opening of the tip while dispensing the adhesive.According to the procedure test for hemostasis valve restriction by pushing the valve housing entirely onto the test pin fixture (the pin inserts through the cap and hemo seal).

• Brand Name: OPTION ELITE IVC FILTER
• Type of Device: 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: 12936939
• MDR Text Key: 283784860
• Report Number: 0001625425-2021-01204
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other