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 01/02/2022

Event Type  malfunction  

Event Description

As reported, the filter of a optease retr filter 55 pierced through of the sheath during use.There was no reported injury to the patient.The optease was store according to the instructions for use (ifu).There was no difficulty removing the device from the packaging.The device was prepped per the ifu and was done so without any difficulty.There was no damage noted to the product packaging.No anomalies were noted on the device prior to use.The device did not pass through any acute bends while in the vessel; however, there was resistance noted while advancing the deployment sheath to the target and while advancing the filter to the deployment target.When the 10f non-cordis sheath was removed, no kinks were noted.The case was completed after the use of a new optease filter.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18034858 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

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

Event Description

As reported, the filter of a optease retr filter 55 pierced through of the sheath during use.There was no reported injury to the patient.The optease was store according to the instructions for use (ifu).There was no difficulty removing the device from the packaging.The device was prepped per the ifu and was done so without any difficulty.There was no damage noted to the product packaging.No anomalies were noted on the device prior to use.The device did not pass through any acute bends while in the vessel; however, there was resistance noted while advancing the deployment sheath to the target and while advancing the filter to the deployment target.When the10f non-cordis sheath was removed, no kinks were noted.The case was completed after the use of a new optease filter.The device will be returned for evaluation.

Event Description

As reported, the filter of a optease retr filter 55 pierced through of the sheath during use.There was no reported injury to the patient.The optease was store according to the instructions for use (ifu).There was no difficulty removing the device from the packaging.The device was prepped per the ifu and was done so without any difficulty.There was no damage noted to the product packaging.No anomalies were noted on the device prior to use.The device did not pass through any acute bends while in the vessel; however, there was resistance noted while advancing the deployment sheath to the target and while advancing the filter to the deployment target.When the10f non-cordis sheath was removed, no kinks were noted.The case was completed after the use of a new optease filter.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.As reported, the filter of a optease retrieval filter 55 pierced through the sheath during use.There was no reported injury to the patient.The optease was store according to the instructions for use (ifu).There was no difficulty removing the device from the packaging.The device was prepped per the ifu and was done so without any difficulty.There was no damage noted to the product packaging.No anomalies were noted on the device prior to use.The device did not pass through any acute bends while in the vessel; however, there was resistance noted while advancing the deployment sheath to the target and while advancing the filter to the deployment target.When the10f non-cordis sheath was removed, no kinks were noted.The case was completed with the use of a new optease filter.The device was returned for analysis.One non-sterile cannula sheath from product optease retr filter 55 was received inside a plastic bag.An obturator was received inserted into the cannula and the filter was returned inside the bag already deployed.Per visual analysis, the cannula was observed pierced/torn approximately at 39 cm from the hub.No anomalies were observed on the filter.No other anomalies were observed on the unit.Per functional analysis, a flushing test was successfully performed, however, water was leaked from the puncture/hole observed during the visual review.Then, the obturator was successfully inserted/withdrawn through the cannula, neither resistance nor obstruction was observed during the insertion/withdrawal test.Per microscopic analysis, sem results showed that the outer surface of the cannula presented bulged/peeled off material along the puncture/hole.The inner surface presented evidence of scratch marks and bulged/peeled off material near the puncture/hole.This type of damage 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.No other anomalies were observed during the sem analysis.A product history review of lot 18034858 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 not confirmed during analysis of the returned device, the insertion/withdrawal test was performed and neither resistance nor obstruction was observed during the insertion/withdrawal test.Additionally, the filter was returned already deployed from the unit.However, the cannula was observed pierced/torn during the visual review.According to the information provided, a non-cordis sheath was being used during the procedure.The sheath returned is part of the optease filter kit.According to the instructions for use, which is not intended as a mitigation of risk, the optease filter has been tested and qualified with the accompanying accessories.The use of any other accessory could result in complications and/or an unsuccessful procedure.The ifu also states: if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.Based on the analysis and the information provided it it not possible to determine what factors may have contributed to the difficulty encountered by the customer.Neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective actions 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: 13403584
• MDR Text Key: 293190396
• Report Number: 9616099-2022-05322
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009390
• UDI-Public: (01)20705032009390(17)240630(10)18034858
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140286
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 18034858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 71 KG