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 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18103039 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.

Event Description

As reported, the conveying sheath of a 55cm femoral optease retrievable vena cava filter is punctured as the filter is being pushed out.There were no reports of patient injury.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the conveying sheath of a 55cm femoral optease retrievable vena cava filter is punctured as the filter is being pushed out.After the complaint device was withdraw, another non-cordis filter was used.There were no reports of patient injury.The filter was not removed and reinserted into the storage tube.The filter was inserted to treat deep vein thrombosis (dvt) of the right lower extremity.The dvt was diagnosed after a documenting a lower extremity fracture.There was no thrombus present at delivery site.The patient received anticoagulation therapy of low molecular heparin.There was no contraindication for anticoagulation therapy.There were no recurrent pulmonary embolisms (pes).Pre and post imaging was completed.The vena cava was of normal size and shape.The target vessel was the inferior vena cava.There were acute bends and tortuosity of the target site vessel as well as the access site vessel.There was some difficulty and resistance/friction while advancing the deployment sheath and the filter to the deployment target.No excess force was used prior to deployment of the filter.The device was stored and prepped in accordance with the instructions for use (ifu).The device was returned for analysis.A non-sterile unit of ¿optease retr filter 55 femoral¿ was received inside of a clear plastic bag.The device was unpacked, the returned parts included the brite tip csi, the obturator and the filter loaded inside the winged storage tube.All components were thoroughly inspected observing that the cannula of the brite tip csi presents a perforated sheath condition located approximately at 18.4 cm from the distal tip.The filter was returned loaded backward inside the winged storage tube, the hook was in the incorrect orientation.The obturator was returned fully inserted inside the cannula of the brite tip csi and does not present any damages or anomalies.Per dimensional analysis the inner and outer diameter of the cannula were measured near the area of perforation and found to be within specification.Per functional analysis, the obturator was withdrawn from the brite tip csi.The filter was reloaded in the correct orientation inside the winged storage tube.The winged storage tube was inserted as far as possible into the hub of the returned csi.The obturator was inserted through the proximal end of the winged storage tube and the filter was advanced through the csi pushing with the obturator until the filter came out through the distal end.Despite the perforated sheath condition, no resistance or obstruction was noticed.The filter expands as expected.The cannula was inspected using a vision system confirming the perforated condition.The filter was evaluated with a vision system to obtain a magnify image.Neither the filter barbs nor the rest of the part present any damages or anomalies.Sem results showed that the conveying sheath of the optease filter presented evidence of punctures, fatigue striations and scratch marks.The fatigue striations found on the inner surface of the conveying sheath are commonly associated with damages caused by material tensile overload.The scratch marks found in the inner and external surface of the sheath 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 scratch marks on the sheath led to the damaged condition found on the received device.It seems the material near the damage was punctured with a sharp object (most likely filter barbs) from the inside of the device.A product history review of lot 18103039 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported ¿catheter sheath introducer (csi) t ~ advancement difficulty¿ and ¿catheter (body/shaft) t ~ tracking difficulty¿ was not confirmed due to the nature of the complaint, it is not possible to reproduce the event in a laboratory environment.The reported ¿filter impeded- perforated sheath¿ was confirmed during analysis of the returned device.The returned bts csi presented a perforated condition most likely caused by the filter barbs.Due to this perforated condition observed on the cannula, it is assumed that the filter was withdrawn and then reloaded with the incorrect orientation inside winged storage tube before returning the device.The exact cause of the perforation on the cannula of the returned csi could not be conclusively determined during the evaluation.It seems the material near the damage was punctured with a sharp object (most likely filter barbs) from the inside of the device.Dimensional analysis results were found within specification.The ifu states: 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 events could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

Event Description

As reported, the conveying sheath of a 55cm femoral optease retrievable vena cava filter is punctured as the filter is being pushed out.There were no reports of patient injury.The device was not returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the conveying sheath of a 55cm femoral optease retrievable vena cava filter is punctured as the filter is being pushed out.There were no reports of patient injury.The device was not returned for analysis.A product history review of lot 18103039 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¿ could not be confirmed as the device was not returned for analysis.With the limited information provided a definitive cause for the event could not be determined, however there are procedural and/or handling factors that can contribute to this type of event.According to the instructions for use, 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 information provided suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

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.

Event Description

As reported, the conveying sheath of a 55cm femoral optease retrievable vena cava filter is punctured as the filter is being pushed out.After the complaint device was withdraw, another non-cordis filter was used.There were no reports of patient injury.The filter was not removed and reinserted into the storage tube.The filter was inserted to treat deep vein thrombosis (dvt) of the right lower extremity.The dvt was diagnosed after a documenting a lower extremity fracture.There was no thrombus present at delivery site.The patient received anticoagulation therapy of low molecular heparin.There was no contraindication for anticoagulation therapy.There were no recurrent pulmonary embolisms (pes).Pre and post imaging was completed.The vena cava was of normal size and shape.The target vessel was the inferior vena cava.There were acute bends and tortuosity of the target site vessel as well as the access site vessel.There was some difficulty and resistance/friction while advancing the deployment sheath and the filter to the deployment target.No excess force was used prior to deployment of the filter.The device was stored and prepped in accordance with the instructions for use (ifu).The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3, and h10 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.

• 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
• 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: 16045973
• MDR Text Key: 306591144
• Report Number: 9616099-2022-06179
• Device Sequence Number: 1
• Product Code: DTK
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F210AF
• Device Catalogue Number: 466F210AF
• Device Lot Number: 18103039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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