MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X150MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number C07150ML

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

This device is not available for testing and evaluation.A review of the manufacturing documentation associated with this lot# 17992353 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 7 x 150mm smart self-expanding stent was being delivered but it was difficult for the complaint device to cross.It was removed once, and the physician noticed the distal tip was frayed.Therefore, it was replaced with another unknown smart stent and it was implanted and the procedure was completed.The smart control locking pin was in place during advancement towards the lesion.The locking pin was not removed before attempting to deploy the smart control stent.The sds was not advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The ifu instructs the user to hold the handle of the smart control sds flat and straight outside the patient and this was done.The tantalum markers (smart control) were observed to open symmetrically because it was not opened.The target vessel was the iliac artery.The product inventory was stored on a shelf.There was no reported patient injury.The device will not be returned for evaluation because it was discarded at the hospital.

Manufacturer Narrative

After further review of additional information received the following sections have been updated g4,g7,h1,h2,h3,h6 as reported, the 7 x 150mm smart self-expanding stent was being delivered but it was difficult for the complaint device to cross.It was removed once, and the physician noticed the distal tip was frayed.Therefore, it was replaced with another unknown smart stent, and it was implanted, and the procedure was completed.The smart control locking pin was in place during advancement towards the lesion.The locking pin was not removed before attempting to deploy the smart control stent.The sds was not advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The ifu instructs the user to hold the handle of the smart control sds flat and straight outside the patient and this was done.The tantalum markers (smart control) were observed to open symmetrically because it was not opened.The target vessel was the iliac artery.The product inventory was stored on a shelf.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17992353 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent delivery system (sds)-ses~ failure to cross¿ and ¿catheter tip~ frayed/split/torn - in patient¿ could not be confirmed.Handling and procedural factors such as vessel characteristics (although unknown) and or the user¿s interaction with the device may have led to the reported events.According to the instructions for use ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12500502
• MDR Text Key: 273331967
• Report Number: 9616099-2021-04881
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• Combination Product (y/n): N
• PMA/PMN Number: K042969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: C07150ML
• Device Catalogue Number: C07150ML
• Device Lot Number: 17992353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1