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

Catalog Number PC0940RXC

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

As reported, the 9x40 precise pro was inserted into intracranial.However, the outer sheath was unable to be retracted during deployment.The complaint device was replaced with another precise pro (same catalog number/ different lot number).There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested about returned device; however, the information was not obtained after multiple attempts.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the 9x40 precise pro was inserted into intracranial.However, the outer sheath was unable to be retracted during deployment.The complaint device was replaced with another precise pro (same catalog number/ different lot number).There was no reported injury to the patient.Additional information was requested about returned device; however, the information was not obtained after multiple attempts.The device was returned for analysis.A non-sterile ¿precise pro rx ous carotid sys¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing the following conditions.The device is fully deployed, and the stent was not retuned for analysis.The hemostasis valve was returned tightly closed.No other outstanding details were observed.Dimensional analysis was performed, the stroke length was measured along with the usable length and both results were found within specification.Functional testing was not performed as the unit was returned and the stent fully deployed and not returned with the sds.However, the mechanism was verified setting the device in the manufacturing condition to simulate the stent deployment process.The mechanism was deployed observing no anomalies during the functional testing.The failure reported by the customer as ¿stent delivery system (sds) deployment difficulty-unable¿ was not confirmed as the unit was returned without the stent.Additionally, the device passed dimensional analysis as the stroke and usable lengths were found within specification.Secondary findings of ¿stent delivery system (sds) deployment difficulty premature deployment¿ was confirmed as the device was returned with the stent fully deployed, there was no stent present.Functional analysis could not be performed as the stent was not received with the device; however, functionality of the deployment mechanism was tested with no difficulties noted.Additionally, no kinks or other damages were noted to the device upon analysis.Therefore, based on the information available for review, limited procedural information provided and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced by the customer.According to the instructions for use, which is not intended to mitigate risk, ¿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.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand (often referred to as the ¿pin-and-pull¿ method).Post-deployment stent dilatation: while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery device from the guidewire.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.(do not remove guidewire.) using fluoroscopy, visualize the stent to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation (standard pta technique) can be performed.¿ the information available does not suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the 9x40 precise pro was inserted into intracranial.However, the outer sheath was unable to be retracted during deployment.The complaint device was replaced with another precise pro (same catalog number/ different lot number).There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested about returned device; however, the information was not obtained after multiple attempts.

• Brand Name: PRECISE PRO RX
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 18586951
• MDR Text Key: 333842498
• Report Number: 9616099-2024-00034
• Device Sequence Number: 1
• Product Code: NIM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 18169176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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: PRECISE PRO RX US CAROTID SYST; UNKNOWN SHEATH
• Patient Race: Asian