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

Model Number 352506070E

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

The guide wire cannot push the filter.

Manufacturer Narrative

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

Event Description

The guide wire cannot push the filter.

Event Description

The guide wire cannot push the filter.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Quality engineer and complaint analyst reviewed the sample returned from the customer.Customer returned delivery catheter sheath, dilator, pusher wire and two cartridge.First cartridge filter was pre-loaded in the cartridge and second cartridge was empty when returned to argon.Most likely the second filter was implanted in the patient by the user.No damage was found on the product.Device was functionally evaluated and cartridge snapped fit with the delivery catheter sheath, pusher wire was used and the dilator advanced the filter, filter passed through the delivery catheter sheath without any issue, filter was loaded and removed in the cartridge multiple times without any issue and filter opened normally.Product complaint mode could not be duplicate during the evaluation and complaint was not confirmed.The most probable cause for the reported issue was most likely the result of the pusher wire or dilator not being fully centered during the procedure.Since the alleged complaint could not be duplicated with the returned device, no further evaluation will be taken.No corrective action is required at this time because a manufacturing defect could not be confirmed.

• 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: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14986279
• MDR Text Key: 296968162
• Report Number: 0001625425-2022-01040
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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: 11416063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• 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): Required Intervention; Other