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

Model Number PC0940RXC

Device Problems Material Frayed (1262); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

As reported, the precise pro was deployed with the use of a non-cordis protection device.After stent deployment the physician attempted to remove the delivery system but there was an intensive resistance felt at the exit port of the non-cordis protection device.The physician pushed the bright tip of the outer member to the tip of the inner shaft, and tried to remove it, but felt resistance.The physician was able to pull it out after doing it several times.It was than noticed that it looked like there was a hangnail on the tip of the inner shaft.There was no reported injury to the patient.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18112694 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and 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.

Event Description

As reported, the precise pro was deployed with the use of a non-cordis protection device.After stent deployment the physician attempted to remove the delivery system but there was an intensive resistance felt at the exit port of the non-cordis protection device.The physician pushed the bright tip of the outer member to the tip of the inner shaft, and tried to remove it, but felt resistance.The physician was able to pull it out after doing it several times.It was than noticed that it looked like there was a hangnail on the tip of the inner shaft.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

Event Description

As reported, the precise pro was deployed with the use of a non-cordis protection device.After stent deployment the physician attempted to remove the delivery system but there was an intensive resistance felt at the exit port of the non-cordis protection device.The physician pushed the bright tip of the outer member to the tip of the inner shaft, and tried to remove it, but felt resistance.The physician was able to pull it out after doing it several times.It was than noticed that it looked like there was a hangnail on the tip of the inner shaft.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

Manufacturer Narrative

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

The precise pro was deployed with the use of a non-cordis protection device.After stent deployment the physician attempted to remove the delivery system but there was an intensive resistance felt at the exit port of the non-cordis protection device.The physician pushed the bright tip of the outer member to the tip of the inner shaft, and tried to remove it, but felt resistance.The physician was able to pull it out after doing it several times.It was than noticed that it looked like there was a hangnail on the tip of the inner shaft.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.There was no reported injury to the patient.The device was returned for analysis.One non-sterile unit of a precise pro rx us carotid syst was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.Per visual analysis, the unit was inserted into an unknown sheath, the stent was not present into the precise unit and the distal tip was received separated.No other anomalies were noted on the cordis unit.Since the unit was returned into an unknown sheath, first it was intended to withdraw the precise unit, resistance/friction was felt during the task.An insertion/withdrawal test was intended with an appropriate lab sample sheath and no difficulties were noted.Due the separated condition noted on the distal tip, a microscopic (sem) analysis was performed.Results showed that the damaged area presented evidence of a cutting pattern and mechanical damage.This observed conditions at the distal tip of the unit was caused due to the interaction with an unknown object that acted like a cutting tool.The mechanical damage marks observed on the analyzed distal tip suggest that the device was induced to a fast cutting/pulling motion by an unknown object that exceeded the material yield strength of the distal tip prior to the separation.However, the exact cause of the event could not be determined during analysis.No other anomalies were observed.A product history record (phr) review of lot 18112694 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) ¿ withdrawal difficulty¿ was confirmed since during functional test while the precise unit was withdraw of the unknown sheath resistance/friction was noted.However, when the test was intended with a lab sample sheath, no difficulties were noted, thus, it is assumed that the unknown sheath was the cause of the resistance/friction found.The reported ¿catheter tip - frayed/split/torn¿ was confirmed since the distal tip was received separated.A sem analysis was performed results showed that the damaged area presented evidence of a cutting pattern and mechanical damage.This observed conditions at the distal tip of the unit was caused due to the interaction with an unknown object that acted like a cutting tool.The mechanical damage marks observed on the analyzed distal tip suggest that the device was induced to a fast cutting/pulling motion by an unknown object that exceeded the material yield strength of the distal tip prior to the separation.According to the instructions for use (ifu) ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ neither the phr review nor the information available suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the precise pro was deployed with the use of a non-cordis protection device.After stent deployment the physician attempted to remove the delivery system but there was an intensive resistance felt at the exit port of the non-cordis protection device.The physician pushed the bright tip of the outer member to the tip of the inner shaft, and tried to remove it, but felt resistance.The physician was able to pull it out after doing it several times.It was than noticed that it looked like there was a hangnail on the tip of the inner shaft.There was no reported injury to the patient.The device will be returned for evaluation.Additional information was requested; 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16489366
• MDR Text Key: 310798311
• Report Number: 9616099-2023-06305
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036525
• UDI-Public: (01)20705032036525(17)240430(10)18112694
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 08/02/2023

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 Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: PC0940RXC
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 18112694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/16/2023; 06/19/2023; 07/25/2023
• Supplement Dates FDA Received: 04/10/2023; 07/13/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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: (MOMAULTRA), BRITE TIP.; (MOMAULTRA).; (MOMAULTRA).; (MOMAULTRA).; BRITE TIP.; BRITE TIP.; BRITE TIP.