MAUDE Adverse Event Report: CORDIS CORPORATION 10FR OPTEASE RETRIEVAL CATH.; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466C210F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17859781 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 blue ring at the far-end of 10f optease retrieval catheter fell off after the recovery while using optease filter.The ring was removed by using the unknown guide wire and the catheter under the blockage of the balloon.There was no any patient injury and the patient¿s outcome was great.This was a case of the removal of inferior vena cava filter.There were no anomalies of the patient`s vessels.There was no vessel tortuosity.The device was stored as per the labeling.The device was prepped per the instructions for use (ifu).There was no any difficulty experienced in prepping the device.There was no visible signs of device/package damage prior to use.The device was not in an acute bend.There was no difficulty advancing the device.There was no unusual force used at any time during the procedure.The procedure was completed.Available images were reviewed.In the first image an x-ray image shows an inflated balloon, a snare device in a guide catheter and a cylindrical radiopaque object that may be the tip of a catheter.There is a graduated marker adjacent, likely located on the surface of the drape.The image appears to be in the region of the pelvis.The second image shows a gloved hand holding a possible guidewire with a separated catheter tip captured on it and a snare device within a guide catheter located on the guidewire distal to the separated catheter tip.The third image shows a gloved hand holding a guidewire with the separated catheter tip located on the guidewire.The device will be returned for evaluation.

Manufacturer Narrative

Event: the catheters, guidewires, and sheaths used for the procedure were non-cordis devices.No product was received for analysis, instead three pictures of the device were received.At the first picture a radiography image is shown where a separated brite tip is visible.At the second picture a separated distal tip inserted into a guide wire can be observed along with a catheter.On the third picture a brite tip separated from the catheter is shown.No other details of the product can be noticed from the pictures.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The blue ring at the far-end of 10f optease retrieval catheter fell off after the recovery while using optease filter.The ring was removed by using the unknown guide wire and the catheter under the blockage of the balloon.There was no patient injury and the patient¿s outcome was great.This was a case of the removal of inferior vena cava filter.There were no anomalies of the patient`s vessels.There was no vessel tortuosity.The device was stored as per the labeling.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no visible signs of device/package damage prior to use.The device was not in an acute bend.There was no difficulty advancing the device.There was no unusual force used at any time during the procedure.The procedure was completed.The product was returned for analysis.A non-sterile product of 10fr optease retrieval catheter was received inside of a clear plastic bag.Per visual analysis the contains on the pouch are one vessel dilator, one csi (catheter sheath introducer) and one catheter.The csi and the vessel dilator do not show any damages; however on the catheter a tip separation condition can be observed.The separated segment was not returned for analysis.No other damages or anomalies were observed on the returned product.Per dimensional analysis measurements taken adjacent to the separation, areas present a diameter reduction.One reading is out of specification due to reduction of the od caused by a pulling stress.Per microscopic analysis two zones present a reduction on the outer diameter; this characteristic is commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material of the catheter was induced to a tensile force that exceeded the catheter material yield strength prior to the separation.Per sem analysis the separation between body/shaft and tip of the catheter presented evidence of elongations on the body/shaft material of the cannula.The elongations found on the body/shaft material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the tip-cannula fusion yield strength prior to the separation.No other anomalies were observed during sem analysis.Initially images were provided for review by a clinician.In the first image an x-ray image shows an inflated balloon, a snare device in a guide catheter and a cylindrical radiopaque object that may be the tip of a catheter.There is a graduated marker adjacent, likely located on the surface of the drape.The image appears to be in the region of the pelvis.The second image shows a gloved hand holding a possible guidewire with a separated catheter tip captured on it and a snare device within a guide catheter located on the guidewire distal to the separated catheter tip.The third image shows a gloved hand holding a guidewire with the separated catheter tip located on the guidewire.A photo analysis was performed by engineers prior to receiving the product with the following results: at the first picture a radiography image is shown where a separated brite tip is visible.At the second picture a separated distal tip inserted into a guide wire can be observed along with a catheter.On the third picture a brite tip separated from the catheter is shown.No other details of the product can be noted in the images.A product history record (phr) review of lot 17859781 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip (optease) separated - in patient¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural factors may have contributed to the separation as evidenced by of elongations on the body/shaft during analysis.According to the safety information in the instructions for use ¿warnings excessive force should not be used to retrieve the filter.Retrieval of the optease retrievable filter should only be attempted in patients in whom an optease retrievable filter has been implanted for no longer than 12 days (12 days inclusive).Precautions if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.It is the responsibility of the physician to use his/her judgement, based on patient safety and clinical experience, regarding the acceptability level of any resistance and/or whether to continue or abort the retrieval attempt.¿ neither the phr review, the procedure images nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h1, and h2 have been updated accordingly.Corrected data: section d10: date device returned to manufacturer.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 10FR OPTEASE RETRIEVAL CATH.
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9285716
• MDR Text Key: 166303463
• Report Number: 9616099-2019-03337
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009369
• UDI-Public: 20705032009369
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 466C210F
• Device Catalogue Number: 466C210F
• Device Lot Number: 17859781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening