MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 7X80 120; CATHETER, BILIARY, DIAGNOSTIC

Model Number C07080MV

Device Problem Partial Blockage (1065)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with this lot# 17920397 presented no issues during the manufacturing process that can be related to the reported complaint.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the tube of the 7mm x 80mm x 120cm smart control self-expanding stent (ses) system was not open for the non-cordis wire.The user tried to thread another wire (unknown) from the proximal end but could not.Unfortunately, he could not change to another stent as he no longer had one in stock.He carefully tried to insert an 18-gauge needle proximally (g18 needle, unknown), noticed resistance and the tube was free.He flushed the stent again.No particles to be seen.The stent was then placed without any problems.There was no reported patient injury and patient was not harmed as everything took place outside the patient.The stent was flushed by an experienced user.The wire was inserted smoothly at the distal end.The wire was stuck on the last 2cm proximal to the tube.2.When removed from the tray the stent was still constrained within the outer member/sheath.A stopcock was not connected to the y-connector of the tuohy borst valve.No difficulty encountered when flushing the stopcock and no difficulty encountered flushing the ses.System was flushed with sodium chloride and heparin.The wire could not be pushed through distal end and stopped about 2 cm from the end.The device is expected to be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections have been updated,d9, g4,g7,h1,h2,h3,h6.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

After further review of additional information received the following sections have been updated accordingly g4,g6,h1,h2,h3 and h6.The tube of the 7mm x 80mm x 120cm smart control self-expanding stent (ses) system was not open for the non-cordis wire.The user tried to thread another wire (unknown) from the proximal end but could not.Unfortunately, he could not change to another stent as he no longer had one in stock.He carefully tried to insert an 18-gauge needle proximally (g18 needle, unknown), noticed resistance and the tube was free.He flushed the stent again.No particles to be seen.The stent was then placed without any problems.The stent was flushed by an experienced user.The wire was inserted smoothly at the distal end.The wire was stuck on the last 2cm proximal to the tube.When removed from the tray the stent was still constrained within the outer member/sheath.A stopcock was not connected to the y-connector of the tuohy borst valve.No difficulty encountered when flushing the stopcock and no difficulty encountered flushing the ses.System was flushed with sodium chloride and heparin.The wire could not be pushed through distal end and stopped about 2 cm from the end.There was no reported patient injury and patient was not harmed as everything took place outside the patient.The device was returned for analysis.A non-sterile unit of ¿ses smart control 7x80 120¿ was received for analysis inside of a plastic bag.The device was unpacked and was placed at one metallic tray to perform the product evaluation.Two kinked bent conditions were observed at 9.5 and 123 cm from the distal tip.These damages were caused by having to fold the product to fit inside the shipping plastic bag.The unit was returned fully deployed and the stent was not included for analysis.No other damages or outstanding details were noted.Functional analysis was performed to determine if resistance/friction or obstruction between the wire lumen and the guide wire can be found at the insertion/withdrawal process.The wire lumen was flushed with water; a syringe filled with water was attached to the hub and positive pressure was applied until the water flowed out of the wire lumen by the distal tip.Neither resistance nor loose material was observed during the flushing procedure.Additionally, per functional analysis, insertion/withdrawal test was performed.A lab sample.035 mm guide wire was inserted and advanced all the way through the inner shaft of the smart control.Then the guidewire was withdrawn completely from the inner shaft.Neither resistance nor friction was felt during the insertion/withdrawn test.Dimensional analysis was performed to verify the correct inner diameter (id) of the inner shaft, measurements were taken at the distal and proximal and dimensional analysis results were found within specification.A product history record (phr) review of lot 17920397 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub (inner shaft)- [guide wire lumen} ~ obstructed - during use¿ was not confirmed.The insertion/withdrawal test through the wire lumen was performed successfully and the dimensional analysis results were found within specification.It is probable that procedural or handling factors such as the user¿s interaction with the device during device preparation might have contributed to the reported event.According to the instructions for use, which are not intended as a mitigation of risk, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SES SMART CONTROL 7X80 120
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12007252
• MDR Text Key: 259606874
• Report Number: 9616099-2021-04642
• Device Sequence Number: 1
• Product Code: FGE
• 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
• Report Date: 07/01/2021

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: 12/31/2021
• Device Model Number: C07080MV
• Device Catalogue Number: C07080MV
• Device Lot Number: 17920397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 07/29/2021; 07/29/2021
• Supplement Dates FDA Received: 06/28/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO WIRE GA35263 M,; UNK G18 NEEDLE; UNK WIRE
• Patient Age: 60 YR
• Patient Weight: 98