MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK ELITE 120CM RE-ENTRY; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number OTB59120A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the needle from a 120cm outback elite re-entry catheter did not deploy as it was trying to get into the true lumen from the subintimal plane of a chronic total occlusion (cto).During fal product analysis, the marker band and distal tip was separated, but it was not returned for analysis.There was no reported patient injury.The device was opened in a sterile field.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the needle from a 120cm outback elite re-entry catheter did not deploy as it was trying to get into the true lumen from the subintimal plane of a chronic total occlusion (cto).There was no reported patient injury.The device was opened in a sterile field.One non-sterile outback elite 120cm re-entry unit was received for analysis inside a plastic bag.The cannula needle was received retracted.The nosecone/distal tip and marker band were separated, but they were not returned for analysis.No other visible anomalies were observed during the analysis.Note: the outback elite catheters are packaged with the cannula deployed.Per dimensional analysis, the usable length of the outback elite was measured and found within specification.Per functional test, a lab sample syringe filled with water was attached to the flush and wire ports located on the handle of the unit and it was successfully flushed.Next, a lab sample 0.014¿ guide wire was inserted into the unit cannula wire port, the guide wire passed through the unit with no difficulty.Then, the cannula was unsuccessfully advanced and retracted via distal movement of the deployment slider.Deployment inability was found.Therefore, a microscopic x-ray analysis was carried out on the unit at the body to nosecone level to try to determine the cause of the impeded cannula.Per x-ray images, the presence of the cannula was confirmed.Moreover, the alignment of the cannula to the true lumen port was inspected and the cannula was stuck with the union of catheter shaft and distal housing/nosecone assembly, which could impede the deployment.Amplified images of the slider mechanism were taken to determine if damage could be present.A dent was found on the assembly of the slider button, which could be associated with an over-forced movement of the deployment slider.Additionally, an sem analysis was performed due to the separated condition of the nosecone/distal tip and marker band.Results showed that the separated area of the nosecone and marker band of the outback 120 cm elite re-entry unit presented evidence of adhesive residues.The adhesive residues on the catheter are a sign that the catheter and nosecone were glued together properly.Therefore, it is likely that the catheter and the nosecone material of the device were induced to a tensile force that exceeded the adhesive yield strength prior to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17973234 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿cannula/needle deployment difficulty-unable to¿ was confirmed through analysis of the returned device.Additionally, a condition of ¿catheter tip/distal tip fractured/separated" was noted during analysis.The exact cause of the issues experienced could not be conclusively determined during analysis.Based on the limited information available for review and the product analysis, procedural/handling factors may have contributed to the needle deployment difficulty experienced as evidenced by the dent found on the assembly button of the slider.The device was returned with the needle/cannula stuck within the union of catheter shaft and distal housing/nosecone assembly which prevented the needle from being deployed.The dent found on the assembly of the button of the slider shows that excessive force may have been used when retracting the needle into the device.However, as the separated condition of the distal tip/nosecone was not reported by the customer, it is unknown what factors may have contributed to the separation noted on the returned device.However, handling factors are possible as evidenced by sem results showing that the separated area presented evidence of adhesive residues.Therefore, it is likely that the cannula material of the device was induced to a tensile force that exceeded the adhesive yield strength prior to the separation.According to the information on safety within the instructions for use (ifu), ¿ensure proper function of the outback elite re-entry catheter by 1) retracting and advancing the cannula tip via proximal and distal movement of the deployment slide, and 2) rotating the rotating knob which rotates the catheter shaft/nosecone.Fully retract the cannula tip via proximal retraction of the handle deployment slide until it stops.Prior to insertion into the body, ensure that the cannula tip is fully retracted into the catheter lateral port and the handle deployment slide is locked in the most proximal position.If not, repeat flushing sequence.¿ the ifu also states, ¿depress handle deployment slide release button and incrementally advance the slide, as appropriate, to extend the cannula tip from the outback elite re-entry catheter lateral port and position it at the vascular target site.Maintain gentle forward pressure on the outback elite re-entry catheter shaft at the sheath.If resistance is felt during deployment, do not apply unnecessary forward push on the outback elite re-entry catheter.It may result in damage to the cannula tip and or separation of the cannula tip.¿ additionally, the ifu reports ¿always visualize tracking of the catheter tip over the aorto-iliac bifurcation.If strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Consider using a 3¿4 mm balloon at low atm to dilate points of resistance, as needed, along delivery track.If the cause cannot be determined, withdraw the outback elite re-entry catheter.Excessive rotation, bending or kinking of the outback elite re-entry catheter may affect its performance.Withdraw the outback elite re entry catheter if it becomes excessively kinked.¿ neither the product analysis nor the phr review suggests that the failures experienced by the customer could be related to the manufacturing process.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: OUTBACK ELITE 120CM RE-ENTRY
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11681358
• MDR Text Key: 247767744
• Report Number: 9616099-2021-04422
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 20705032067574
• UDI-Public: 20705032067574
• Combination Product (y/n): N
• PMA/PMN Number: K150836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 17973234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1