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

Model Number 352506070E

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Sample expected to return for evaluation.

Event Description

Ivc filter poked hole and started to exit side wall of sheath md cut sheath inserted wire and exchanged for a new set up.

Event Description

Ivc filter poked hole and started to exit side wall of sheath md cut sheath inserted wire and exchanged for a new set up.

Manufacturer Narrative

The customer returned the delivery catheter sheath for review.The delivery catheter sheath was found to be bent and damaged from use.It was not possible to replicate the failure that the user experienced since no other components of the device were returned and the damage done on the delivery catheter sheath from the user prevented inspection for potential defects that may have caused the failure.The complaint cannot be confirmed.

Event Description

Ivc filter poked hole and started to exit side wall of sheath md cut sheath inserted wire and exchanged for a new set up.

Manufacturer Narrative

The sample was returned and an investigation is in progress.A final report will be submitted once the investigation has been completed.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creed rd; athens TX 75751
• MDR Report Key: 11853468
• MDR Text Key: 254819443
• Report Number: 0001625425-2021-00922
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11355398
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention