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

Model Number 352506070E

Device Problem Difficult to Insert (1316)

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

Event Date 02/28/2022

Event Type  malfunction  

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

When trying to pull out the dilator after inserting the sheath, the dilator would not come out and the proximal ro marker dragged down on top of the distal marker.They had to pull a separate kit.

Event Description

When trying to pull out the dilator after inserting the sheath, the dilator would not come out and the proximal ro marker dragged down on top of the distal marker.They had to pull a separate kit.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot could not be conducted since a lot number was not provided.Quality engineer and complaint analyst reviewed the sample returned from the customer.The customer returned only the dilator.Visual inspection confirmed that one of the marker bands was missing from the dilator.It was also observed that the hub and approximately 3 cm of the dilator were missing.Since the delivery catheter sheath was not returned, an evaluation of the reported issue could not be conducted.A definite root cause for the reported issue could not be established with only one of the components returned for review.Possibly too much force was applied to the dilator when removing from the delivery catheter sheath that resulted in the marker band detaching but it cannot be determined what caused the resistance without a review of the delivery catheter sheath.Since a definite root cause could not be established based on the review of the returned dilator, establishing a corrective action is not possible.

• 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: 13767594
• MDR Text Key: 291643361
• Report Number: 0001625425-2022-00962
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• 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): Other