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

Model Number 466F210A

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

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.A device history record (dhr) review of lot 17543882 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

As reported, after the optease retrieval filter was put into the sheath, the side of the filter punctured through the delivery sheath.It was then withdrawn and it was found that the whole filter was compressed.There was no reported patient injury.The product was clinically used and will be returned for analysis.

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.

Event Description

As reported, after the optease retrieval filter was put into the sheath, the side of the filter punctured through the delivery sheath.It was then withdrawn and it was found that the whole filter was compressed.There was no reported patient injury.The product was clinically used and will be returned for analysis.The access site location was the femoral artery.There was no calcification nor scarring at the access site.The target lesion was a venous thrombus.There was no calcification, tortuosity, nor stenosis present at the target site.The product was stored and handled according to the instructions for use (ifu).The device was prepped per the ifu.There was no difficulty experienced in prepping the device.There were no anomalies noted prior to inserting into the patient.There was no resistance encountered while withdrawing the device from the patient.The device was replaced with a new device to successfully complete the procedure.

Manufacturer Narrative

As reported, after the optease retrievable vena cava filter was put into the sheath.When advancing, the side of the filter punctured through the delivery sheath.It was then withdrawn and it was found that the whole filter was compressed.There was no reported patient injury.The product was clinically used and will be returned for analysis.The access site location was the femoral artery.There was no calcification nor scarring at the access site.The target lesion was a venous thrombus.There was no calcification, tortuosity, nor stenosis present at the target site.The product was stored and handled according to the instructions for use (ifu).The device was prepped per the instruction for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted prior to inserting into the patient.There was no resistance encountered while withdrawing the device from the patient.The device was replaced with a new device to successfully complete the procedure.One non-sterile optease retrievable vena cava filter 55, the components received were: sheath introducer, an obturator and vessel dilator, they were received inside of a plastic bag.The optease retrievable filter was not received; the vessel dilator was received inserted in the sheath introducer.No anomalies or damages were found on the received components.No functional test could be performed since the involved optease retrievable filter was not received for analysis.A review of the device history record for lot 17543882 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The complaints reported by the customer as ¿filter- perforated sheath¿ and ¿filter ¿ shape altered - in patient¿ were not confirmed since the involved filter was not received for analysis and also, no punctures nor other damages were observed on the received sheath introducer.The cause of the events experienced by the customer could not be conclusively determined.Procedural factors may have contributed to the event.As the ifu recommends ¿place the appropriate end of the storage tube (containing the opteaser retrievable filter), as far as possible into sheath introducer hemostasis valve.The appropriate end is indicated by the printed arrows and text on the storage tube.The arrows will point into the sheath introducer hemostasis valve and can only be inserted in this orientation.Slowly advance the filter into the sheath introducer by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer.To restore hemostasis, withdraw the storage tube out of the sheath introducer hemostasis valve.The storage tube can be fixed on the hub-end of the obturator by sliding it over the bump.Continue to advance the filter until the marker on the obturator is positioned at the sheath introducer hemostasis valve.This indicates that the filter is at the distal tip of the sheath introducer but still fully within the sheath introducer¿.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.

• Brand Name: OPTEASE RETR FILTER 55
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7052648
• MDR Text Key: 93300896
• Report Number: 9616099-2017-01608
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 466F210A
• Device Catalogue Number: 466F210A
• Device Lot Number: 17543882
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2016
• 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