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 Consequences Or Impact To Patient (2199)

Event Date 10/31/2020

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# 17948518 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

As reported, the 55 optease retrievable vena cava filter couldn't be pushed up in the process of advancing the filter along the unknown delivery sheath.After removing the filter together with the unknown delivery sheath, it was found that the unknown sheath was broken, the filter was stuck.Therefore, it was replaced with another unknown product to complete the operation.There was no reported patient injury.The optease filter was used during the implantation of an inferior vena cava filter in a patient with venous thrombosis.The device will be returned for analysis.

Manufacturer Narrative

The 55 optease retrievable vena cava filter could not be pushed up in the process of advancing the filter along the 6f non cordis sheath 11cm short.After removing the filter with the unknown delivery sheath, it was found that the unknown sheath was broken and the filter was stuck.Therefore, it was replaced with another unknown product to complete the operation.There was no reported patient injury.The device was used inside the patient.The damage was noted during use.The device was prepared as specified by the instructions for use (ifu).There was no apparent damage to the device noticed prior to use.The vessel characteristics were normal.No acute bends or tortuosity noted.There was difficulty and resistance/friction while advancing the filter to the deployment target.The obturator remained fixed while the deployment sheath was pulled back over the obturator.It was not verified under fluoroscopy that the filter was not in a side vessel.The optease filter was used during the implantation of an inferior vena cava filter in a patient with venous thrombosis.The device was returned for analysis.Per visual analysis, a perforated condition was seen on the cannula sheath by the filter barbs.Per microscopic analysis, amplified images were taken to better visualize 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 appeared that the cannula material was punctured with a sharp object from the inside of the cannula, in this case the barbs of the filter, which may have led to the perforated condition found on the received component.Additionally, the filter was revised under the vision system, giving focused attention to the barbs.No anomalies were found.A review of the manufacturing documentation associated with lot 17948518 was performed and no defective units were rejected during the final assembly of this lot.A functional analysis was not performed.No other component was returned for analysis.A product history record (phr) review of lot 17948518 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 due to the perforated condition seen on the cannula during the visual analysis.However, the exact cause of the condition could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to the reported condition on the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.It should be noted the event describes an interaction with a 6f 11 cm non-cordis sheath; however, the concomitant sheath with the stent perforating the cannula was the cordis sheath provided with the optease filter kit, as recommended.According to the 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.

Manufacturer Narrative

After further reviewed of additional information received the following sections have been updated accordingly : a2, a3, a4, b7, d10, h1, h2.

• 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; FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10924645
• MDR Text Key: 218931055
• Report Number: 9616099-2020-04091
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17948518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2020
• 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
• Treatment: 11CM SHORT SHEATH,; 6F TERUMO; UNKNOWN ANOTHER PRODUCT; UNKNOWN ANOTHER PRODUCT; UNKNOWN SHEATH; UNKNOWN ANOTHER PRODUCT; UNKNOWN SHEATH
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG