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

Catalog Number	PC0740RXC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A precise pro rx carotid self-expanding stent could not be used to do a carotid artery stenting (cas) because it could not cross the blood vessel and was bent.The device was received for evaluation and was partially deployed.It was further confirmed that the partially deployed condition occurred during use in the patient.Multiple attempts to gather additional information have been made and have been unsuccessful.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid system¿ 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 at 9 and 82 cm from the distal tip.Also, the hypotube presents a kinked condition located approximately at 7 from the proximal end.The device is partially deployed.The hemostasis valve was returned open.No other outstanding details were noticed.Dimensional analysis was performed to verify the correct outer diameter of the stent crossing profile.Measurements were taken at two different places and results were found within specification.Functional test was not performed due to the nature of the complaint; the reported malfunction is not possible to reproduce in a laboratory environment.A product history record (phr) review of lot 18177086 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)-failure to cross¿ could not be confirmed due to the nature of the complaint and due to the outer diameter of the stent crossing profile was found within specification.However, according with the evaluation outcomes the ¿stent delivery system (sds)~kinked/bent¿ was confirmed.Also, a partial stent deployment was observed.The exact cause of the 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 (ifu) ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ 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 or Problem Description
As reported, a precise pro rx carotid self-expanding stent could not be used to do a carotid artery stenting (cas) because it could not cross the blood vessel and was bent.There was no reported patient injury.The device was received for evaluation and was partially deployed.It was further confirmed that the partially deployed condition occurred during use in the patient.Multiple attempts to gather additional information have been made and have been unsuccessful.

• Brand Name: PRECISE PRO RX
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18155050
• Report Number: 9616099-2023-06637
• Device Sequence Number: 17759260
• Product Code: NIM
• UDI-Device Identifier: 20705032036464
• UDI-Public: 20705032036464
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 18177086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown