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

Catalog Number PC0630XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

As reported, the doctors stated that when the device was removed from the original box, the stent was already partially released.The issue was identified before the procedure.Therefore, the doctor could not use the device on the patient.The case was completed with a non-cordis device due to not having another precise of correct size.There was no reported injury to the patient.The device was not used.There was no damage to the product packaging.The device will be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available 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 doctors stated that when the device was removed from the original box, the stent was already partially released.The issue was identified before the procedure.Therefore, the doctor could not use the device on the patient.The case was completed with a non-cordis device due to not having another precise of correct size.There was no reported injury to the patient.The device was not used.There was no damage to the product packaging.The device will be returned for evaluation.

Manufacturer Narrative

The doctors stated that when the device was removed from the original box, the stent was already partially released.The issue was identified before the procedure.Therefore, the doctor could not use the device on the patient.The case was completed with a non-cordis device due to not having another precise of correct size.The device was not used.There was no damage to the product packaging.There was no reported injury to the patient.The device was returned for analysis.A non-sterile unit of ¿precise pro rx ous carotid sys¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed on one metallic tray to be inspected.A thorough inspection was performed observing that the unit present one kink located approximately at 98 cm from the distal tip.The stent is fully deployed and was returned for analysis.The stent does not present any damages or anomalies and it is expanded as expected.The hemostasis valve was returned tight closed.No other outstanding details were noticed.The stroke length was measured, and the results were found within specification.Functional analysis was not performed due to the unit was returned fully deployed.However, the deploying mechanism was actuated manually and performed as expected.A product history record (phr) review of lot 18106334 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/prior to use¿ was not confirmed due to the unit was returned fully deployed and the mechanism is working properly indicating that the device performed as expected.However, one kink was observed on the device.The exact cause of this kink observed on the device could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to this issue.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.¿ 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.

Event Description

As reported, the doctors stated that when the device was removed from the original box, the stent was already partially released.The issue was identified before the procedure.Therefore, the doctor could not use the device on the patient.The case was completed with a non-cordis device due to not having another precise of correct size.There was no reported injury to the patient.The device was not used.There was no damage to the product packaging.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18106334 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.

• Brand Name: PRECISE PRO RX OUS
• 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 FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17238761
• MDR Text Key: 318560856
• Report Number: 9616099-2023-06542
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062357
• UDI-Public: (01)20705032062357(17)240331(10)18106334
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

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: 03/31/2024
• Device Catalogue Number: PC0630XCE
• Device Lot Number: 18106334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/04/2023; 09/13/2023
• Supplement Dates FDA Received: 07/28/2023; 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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: NO INFO AVAILABLE.