MAUDE Adverse Event Report: OPTION ELITE RETRIEVABLE VENA CAVA FILTER

Model Number	352506070E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
Event or Problem Description
Filter would not pass through the sheath.Sheath fractured.
Event or Problem Description
Filter would not pass through the sheath.Sheath fractured.
Additional Manufacturer Narrative
The customer returned two delivery catheter sheaths.Visual inspection of both delivery catheter sheaths found body fluid/dry blood, a kink in both delivery catheter sheaths, and both filters stuck within the delivery catheter sheaths.Functional evaluation of the devices in which the dilator was inserted into the delivery catheter sheath, found the dilator would not pass thru the kinked area.Excessive force was applied to pass the dilator through the damaged area to advance the filter.Visual inspection of the sheath did not find any delamination, however, due to the damaged/kinked area, the complaint was confirmed.A definite root cause could not be established, however, the most probable root cause is that the kink on the delivery catheter sheath occurred during the procedure in the user environment.Another possible root cause could be related to the mishandling of the product during packaging, and/or shipment.Both the ifu and instructions on the package instruct the user to not use the device if the product is damaged.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: OPTION ELITE
• MDR Report Key: 12657881
• Report Number: 0001625425-2021-01101
• Device Sequence Number: 4852612
• Product Code: DTK
• UDI-Device Identifier: 00886333217519
• UDI-Public: 886333217519
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K133243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Model Number: 352506070E
• Device Lot Number: 11382796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other