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 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, in the process of conveying the optease retrievable 55 filter, the outer sheath was pierced, and the filter could not be pushed.There was no patient injury.A 5f cordis femoral artery sheath angiography and 6f sheath that comes with the product were used.The indication for filter insertion was deep vein thrombosis of lower extremities.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The device did not kink nor bend at any time.The other devices used with the product did not kink nor bend at any time.The product, or any of the other devices used with it, had not been resterilized.The insertion difficulty was not caused by a blockage of possibly injectable material.The procedure was completed by resetting the sheath and using a new filter.The product is expected to be returned for evaluation.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, in the process of conveying the optease retrievable 55 filter, the outer sheath was pierced, and the filter could not be pushed.There was no patient injury.A 5f cordis femoral artery sheath angiography and 6f sheath that comes with the product were used.The indication for filter insertion was deep vein thrombosis of lower extremities.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The device did not kink nor bend at any time.The other devices used with the product did not kink nor bend at any time.The product, or any of the other devices used with it, had not been resterilized.The insertion difficulty was not caused by a blockage of possibly injectable material.The procedure was completed by resetting the sheath and using a new filter.The device was returned for evaluation.A non-sterile optease retr filter 55 cannula sheath with a retrievable filter inside, were received for analysis in a plastic bag.Per visual analysis, the filter was returned with the filter barbs protruding through the cannula sheath.Also, kinks were observed in the cannula sheath body near the stuck filter.No other anomalies could be observed by the naked eye.Per functional analysis, an attempt to pass the filter through the csi cannula sheath was performed.Despite the kinks on the cannula sheath, a lab sample obturator was introduced into the cannula sheath up to the filter in order to push the filter.However, the filter could not be advanced forward due to the filter barb protruding the cannula sheath wall.Therefore, a lab sample obturator was introduced into the cannula sheath at the distal tip, and the filter was moved backward to liberate it from its stuck position, and then, pushed forth once again.This time, the filter was able to be pushed all the way through and out of the sheath.Besides the kinks in the cannula sheath and the filter barb perforating the sheath, no other anomalies found.Per microscopic analysis, the cannula sheath kinked, and perforated area was inspected under the vision system.Amplified images of the cannula sheath were taken for a better observation of the sheath perforated condition.The type of damage observed on the cannula is that of damages commonly caused during the interaction of the cannula material with a sharp object or mechanical damage.In this case, the barbs of the filter caused the perforated condition found on the cannula sheath.Additionally, the filter barbs were also inspected under the vision system and no anomalies were found.A product history review of lot 17988678 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported ¿filter ¿ impeded - perforated sheath¿ was confirmed during analysis of the returned device.The exact cause of the reported event could not be conclusively determined, however review of the analysis and the available information suggests procedural and/or handling factors, such as operator technique leading to kinking of the sheath, that may have contributed to the reported event.The filter/ filter barbs were inspected under the vision system and no anomalies were found.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, product analysis, nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• 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
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13052786
• MDR Text Key: 284524816
• Report Number: 9616099-2021-05217
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009390
• UDI-Public: (01)20705032009390(17)231130(10)17988678
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17988678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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 Sex: Male
• Patient Weight: 65 KG
• Patient Race: Asian