MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETR FILTER 55; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F210A

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with this lot# 17911454 presented no issues during the manufacturing process that can be related to the reported complaint.However, it will be submitted within 30 days upon receipt.

Event Description

After normal surgical angiography, the long sheath of a 55 optease retrievable filter was placed and pushed the ¿recyclable filter; but the filter was to difficult to pass through the iliac vein.With great resistance, a little force push or not, and then the whole was withdrawn.¿ it was found that the filter barb has punctured the ¿input sheath¿ and the product cannot be used.What was meant by filter was placed and pushed the ¿recyclable filter was the long sheath was placed and then the retrievable filter was advanced.What was meant by the filter barb has punctured the ¿input sheath¿ was it found the filter bard has punctured the delivery sheath after removal as a unit.There were no acute bends or tortuosity.There was no difficulty or resistance/friction while advancing the deployment sheath to the deployment target.There was difficulty or resistance/friction while advancing the filter to the deployment target.The obturator remains fixed while the deployment sheath was pulled back over the obturator.It was verified under fluoroscopy that the filter was not in a side vessel.The device was removed successfully from the patient.The procedure completed with another opteasethere was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

After normal surgical angiography, the long sheath of a 55 optease retrievable filter was placed and pushed the ¿recyclable filter but the filter was too difficult to pass through the iliac vein.After great resistance and a little forced push, the whole system was withdrawn.¿ it was found that the filter barb had punctured the ¿input sheath¿ and the product could not be used.What was meant by filter was placed and pushed was the ¿recyclable filter was the long sheath was placed and then the retrievable filter was advanced".What was meant by the filter barb has punctured the ¿input sheath¿ was it was found that the filter bard had punctured the delivery sheath after removal as a unit.There were no acute bends or tortuosity.There was difficulty or resistance/friction while advancing the filter to the deployment target.The obturator remains fixed while the deployment sheath was pulled back over the obturator.It was verified under fluoroscopy that the filter was not in a side vessel.The device was removed successfully from the patient.The procedure was completed with another optease.There was no reported patient injury.The device was returned for analysis.Per visual analysis, the obturator and the vessel dilator were returned.A perforated condition was found on the cannula sheath by the filter barbs.No other anomalies were found along the device.No other component was returned for analysis.A functional analysis was not performed.Per microscopic analysis, amplified images were taken to a better observation of the perforated sheath.The type of damage present on the cannula is commonly caused during the interaction of the cannula material with a sharp object or mechanical damage, it seems the cannula material was punctured with a sharp object from the inside of the cannula, in this case the barbs of the filter, that could probably led to the perforated condition found on the received component.Additionally, the filter was viewed under the vision system, with special attention given to the barbs and no anomalies were found.A product history record (phr) review of lot 17911454 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter impeded - perforated sheath¿ was confirmed since a perforated condition was found on the cannula during visual analysis.However, the exact cause of this condition could not be conclusively determined during the analysis.Procedural and/or handling factors, such as operator technique, may have contributed to the reported event since the device did not present any obvious indication of manufacturing defect or anomaly.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the design or manufacturing process of the unit; therefore, no corrective or preventive actions will be taken.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11085334
• MDR Text Key: 224758969
• Report Number: 9616099-2020-04154
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17911454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR