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

Catalog Number 466F210AF

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.The device was received for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the optease retr filter 55 femoral was stuck in the conveying sheath, which made the solid pusher unable to push the filter, and finally the filter failed to release.There was no patient injury.The device was returned for evaluation.Product analysis revealed a punctured/cut condition on the cannula.

Manufacturer Narrative

As reported, the optease retr filter 55 femoral was stuck in the conveying sheath, which made the solid pusher unable to push the filter, and finally the filter failed to release.There was no patient injury.The device was returned for evaluation.Product analysis revealed a punctured/cut condition on the cannula.The device was returned for analysis.One non-sterile unit of catheter optease retr filter 55 femoral was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, the catheter sheath introducer, the obturator, the filter, and the vessel dilator, were returned for analysis.The filter was already deployed, was thoroughly inspected and no anomalies were noted.The vessel dilator was kinked on the distal tip, and the obturator was kinked at 43.8 cm from the distal tip.The catheter sheath introducer was found punctured/cut.No other anomalies were noted on the components returned.Dimensional analysis was performed to verify the correct vessel dilator and csi inner diameter (id) and outer diameter (od) and the obturator od, measurements were taken near the damage found.These measurements were verified and were found to be within specification.A functional test could not be performed since the filter was already deployed.Due the puncture/cut found on the cannula, a sem analysis was performed, and results showed that the punctured/cut area of the cannula on the optease retr filter 55 femoral unit presented evidence of outward directed elongations on the external surface and scratch marks on the internal surface of the material near the damaged condition.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed material elongations and scratch marks on the unit¿s outer and inner surfaces could probably led to the punctured condition found on the received unit.Based on the available evidence, it seems the unit¿s material was punctured with a sharp object from the inside of the unit.No other anomalies were observed during the sem analysis.A product history review of lot 18053187 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported event by the customer as ¿filter ¿ impeded¿ was not confirmed since the filter was already deployed.A kinked conditions were noted on the vessel dilator and the obturator; however, dimensional analysis was performed, and it was found within specification.The reported event by the customer as ¿catheter (body/shaft) ¿ puncture/cut¿ was confirmed since a puncture/cut was found on the cannula.The exact cause for the event could not conclusively be determined, however, procedural factors may have contributed to the reported issue, as a sem analysis of the unit presented evidence of outward directed elongations on the external surface and scratch marks on the internal surface of the material near the damaged condition.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.

Manufacturer Narrative

A device history record review of lot 18053187 was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 15148426
• MDR Text Key: 301253357
• Report Number: 9616099-2022-05874
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032073599
• UDI-Public: (01)20705032073599(17)240831(10)18053187
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F210AF
• Device Lot Number: 18053187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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
• Treatment: UNK SHEATH