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

Model Number PC0630RXC

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot #18143587 presented no issues during the manufacturing process that could be related to the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the distal part of the precise pro rx carotid self-expanding stent was discovered broken by about 3mm during delivery through the filter wire and its use was discontinued.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device is expected to be returned for evaluation.

Manufacturer Narrative

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

Event Description

All procedures were carried out according to the instructions for use (ifu).No further information could be obtained.The product was returned for evaluation and the catheter tip was found separated.The separated part was not delivered from the hospital to the dealer and was returned in the same condition as it was delivered.It did not remain or affect the patient's body.A device picture was received for review.

Manufacturer Narrative

The distal part of the precise pro rx carotid self-expanding stent was discovered broken by about 3 mm during delivery through the filter wire and its use was discontinued.All procedures were carried out according to the instructions for use (ifu).No further information could be obtained.The product was returned for evaluation and the catheter tip was found separated.The separated part was not delivered from the hospital to the dealer and was returned in the same condition as it was delivered.It did not remain or affect the patient's body.A device picture was received for review.There was no reported patient injury.The device was returned for analysis.One non-sterile units of product ¿precise pro rx us carotid system¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected, and it was noticed that the stent was not deployed.In addition, the hemostasis valve was closed, a kink condition was found approximately at 23.5 cm from the distal tip and the catheter tip was found separated and not returned.No other damages or anomalies were observed on the returned device.The catheter tip was observed under the vision system to magnify the damage.Microscopic (sem) analysis was not performed due to the material resulting characteristics caused by the separation are visible with the magnification obtained with the vision system.The separated area was inspected with the vision system observing that both separated edges present evidence of elongations on the plastic material, plastic deformation, and diameter reduction on the body shaft.Also, a diameter reduction and plastic deformation on the metallic material (braid wire) was observed.The characteristics found on the materials of the unit are commonly associated with separations caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to a tensile/twist forces that exceeded the material yield strength prior to the separation.A product history record (phr) review of lot 18143587 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip-cracked¿ was not confirmed since the tip was not found cracked.However, the tip was found separated and not returned, the elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Procedural factors and handling process such as the user¿s interaction with the device during use may have contributed to the reported events.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.¿ the product evaluation does not suggest that the reported event experienced by the customer are related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th 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: 17098110
• MDR Text Key: 316964373
• Report Number: 9616099-2023-06515
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036426
• UDI-Public: (01)20705032036426(17)240831(10)18143587
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC0630RXC
• Device Catalogue Number: PC0630RXC
• Device Lot Number: 18143587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2022
• 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: UNKNOWN.