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

Model Number 466F210AF

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

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

Event Date 06/04/2021

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

Event Description

When the operator pushed the 55cm femoral optease retrievable vena cava into the non-cordis sheath, it was found that the sheath was cracked when pushing the filter into the sheath and the optease could not be delivered to the patient¿s body.It was then replaced with a new unknown filter and sheath to complete the procedure.There was no reported patient injury.The operator was trained to use the device.The indication for filter insertion was to prevent dvt/pe.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 been resterilized.The insertion difficulty was not caused by a blockage of possibly injectable material.The device will 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.

Manufacturer Narrative

Complaint conclusion: when the operator pushed the 55cm femoral optease retrievable vena cava into the sheath (unknown), it was found that the sheath was broken and the optease could not be delivered to the patient¿s body.It was then replaced with a new filter (unknown) to complete the procedure.The operator was trained to use the device.There was no reported patient injury.The device was returned for analysis.A non-sterile product ¿optease retr filter 55 femoral¿ was received.Per visual analysis, the returned components were the filter, the tube storage, the vessel dilator, the obturator, and the csi.The tube storage was inserted over the proximal section of the obturator.The obturator presented a kinked/bent condition located at 45 cm from the distal tip.A kinked/bent condition was observed on the vessel dilator located at 38 cm from the distal tip.The filter was stuck inside the distal section of the csi sheath.The sheath (cannula) of the csi presented a frayed/split/torn condition on the distal area caused by the filter barbs.No damages or anomalies were observed at the returned parts.A functional analysis was not performed due to the perforated condition of the csi sheath.Per microscopic analysis, the damaged area of the canula was inspected using a vision system to obtain a magnified image observing that the barbs of the filter torn the cannula walls.A product history record (phr) review of lot 17955288 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 by analysis.However, the exact cause of this condition could not be conclusively determined.Procedural and/or handling factors, such as operator technique, or vessel characteristics, although unknown, may have contributed to the reported event.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 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12098908
• MDR Text Key: 259423928
• Report Number: 9616099-2021-04672
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 466F210AF
• Device Catalogue Number: 466F210AF
• Device Lot Number: 17955288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 07/07/2021; 08/06/2021
• Supplement Dates FDA Received: 08/02/2021; 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO SHEATH.; TERUMO SHEATH
• Patient Age: 66 YR
• Patient Weight: 68