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

Model Number PC0830RXC

Device Problem Difficult to Remove (1528)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

As reported, an 8mm x 30mm precise pro rx self-expanding stent (ses) delivery system was unable to cross the target vessel and the catheter became stuck.There was no reported injury to the patient.This was during a procedure to treat a carotid lesion.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18143588 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.

Manufacturer Narrative

Complaint conclusion: an 8mm x 30mm precise pro rx self-expanding stent (ses) delivery system was unable to cross the target vessel and the catheter became stuck.This was during a procedure to treat a carotid lesion.There was no reported injury 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 was placed at one metallic tray to be inspected.A thorough inspection was performed on the unit observing two kinks located approximately on 16.6 and 130.5 cm from the distal tip.Also, a twisted condition was observed located approximately on130.5 cm from the distal tip with a length of 4 cm.The device is fully deployed, and the stent was not returned for analysis.The stainless-steel coil (inner shaft) presents an unravel condition.The hemostasis valve was returned open.No other outstanding details were noticed.Dimensional analysis was performed to verify the correct outer diameter (od) of the stent crossing profile.Measurements were taken at two different places and results were found within specification.Functional test for failure to cross was not due to the nature of the complaint; the reported malfunction is not possible to reproduce in a laboratory environment.The damaged area was inspected with a vision system to obtain a magnified image.A twisted condition was confirmed.A product history record (phr) review of lot 18143588 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The reported ¿stent delivery system (sds)~failure to cross¿ and ¿stent delivery system (sds)~withdrawal difficulty-from vessel¿ could not be confirmed due to the nature of the complaint and due to the outer diameter (od) of the stent crossing profile was found within specification.However, according with the evaluation outcomes the malfunction ¿stent delivery system (sds)~kinked/bent¿ and ¿stainless steel coil (inner shaft) ~ unraveled/stretched¿ was confirmed.The exact cause of observed damages 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, ¿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.¿ the product analysis does not suggest that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, an 8mm x 30mm precise pro rx self-expanding stent (ses) delivery system was unable to cross the target vessel and the catheter became stuck.There was no reported injury to the patient.This was during a procedure to treat a carotid lesion.Additional information was requested but was not provided.The device will be returned for evaluation.

• 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: 17315229
• MDR Text Key: 319224758
• Report Number: 9616099-2023-06549
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036488
• UDI-Public: (01)20705032036488(17)240831(10)18143588
• 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: 10/20/2023

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 Model Number: PC0830RXC
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 18143588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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