MAUDE Adverse Event Report: CORDIS US. CORP PRECISE PRO RX; STENT, CAROTID

Catalog Number PC0520RXC

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18117996 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after flushing a 5mm x 20mm precise pro rx carotid self-expanding stent (ses) delivery system, the stent was deployed prior to entering an unknown guiding sheath.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) without difficulty.The precise pro delivery system was being advanced along an unknown guidewire when the stent deployed; however, there was no resistance/friction between the delivery system and the guidewire.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: after flushing a 5mm x 20mm precise pro rx carotid self-expanding stent (ses) delivery system, the stent was deployed prior to entering an unknown guiding sheath the device was stored and prepped per the instructions for use (ifu) without difficulty.The precise pro delivery system was being advanced along an unknown guidewire when the stent deployed; however, there was no resistance/friction between the delivery system and the guidewire.There were no reported injuries to the patient.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid syst¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and placed at one metallic tray to be inspected.A thorough inspection was performed on the unit observing the following conditions: the device is fully deployed.The stent was not retuned for analysis.The hemostasis valve was returned dissembled.No other outstanding details were observed.Dimension analysis results were found within specification.Functional test was not performed due to the unit was returned fully deployed.However, the mechanism was inspected simulating the deployment process and no anomalies were observed.A product history record (phr) review of lot 18117996 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds) ~ deployment difficulty - premature/during prep¿ was not confirmed due to the unit was returned fully deployed and the dimensional analysis was found within specification.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.Open the outer box to reveal the pouch containing the stent and delivery system.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.See warnings section.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and remove the tray.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.Attach a 5-cc syringe filled with heparinized saline to the open stopcock and apply positive pressure until saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.Close the stopcock attached to the tuohy borst y connection.Extract the stent delivery system from the tray.Examine the device for any damage.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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.Neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17584559
• MDR Text Key: 321540866
• Report Number: 9616099-2023-06582
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036389
• UDI-Public: (01)20705032036389(17)240531(10)18117996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: PC0520RXC
• Device Lot Number: 18117996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• 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
• Treatment: GUIDING CATHETER