MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER

Catalog Number 352506070E

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided, so the device history record could not be reviewed.Photos of the retrieved object were provided by the customer; however, the actual product was not returned for evaluation.It appears that the introducer sheath lining may have delaminated but that cannot be confirmed without inspecting the actual product.Since the device is not available for return, no further evaluation can be conducted at this time.

Event Description

During jugular filter placement, an object came out of the introducer sheath.The piece was retrieved; however, the patient is still in the hospital and being monitored because it is unknown if all pieces were retrieved.

Manufacturer Narrative

The sheath lining filament was returned for review; however, the filter, sheath, or pusher were not returned.Without the filter and/or entire sheath assembly available for evaluation, further conclusions cannot be drawn.Since the main device is not available for return, no further evaluation can be conducted at this time.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 7180525
• MDR Text Key: 96961923
• Report Number: 1625425-2017-00190
• Device Sequence Number: 1
• Product Code: DTK
• 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: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention