MAUDE Adverse Event Report: CORDIS US. CORP SMART RADIANZ; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	SR10060L
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a 10mm x 60mm smart radianz self-expanding stent (ses) delivery system was frayed, and a vassallo 18 floppy guidewire could not be inserted.An unknown device was used as a replacement and the procedure was completed.There were no reported injuries to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.
Additional 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.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the tip of a 10mm x 60mm smart radianz self-expanding stent (ses) delivery system was frayed, and a vassallo 18 floppy guidewire could not be inserted.An unknown device was used as a replacement and the procedure was completed.There were no reported injuries to the patient.Additional information was requested but was not provided.The device was returned for evaluation.A non-sterile "smart radianz 10x60 150cm" was received for analysis in a plastic bag.The device was unpacked to perform the product evaluation.Upon inspection, the following conditions were noted: the distal tip was frayed, while the stent and clip were correctly mounted in the manufacturing position.No additional damage or notable abnormalities were observed aside from the frayed distal tip.Further examination of the distal tip using a vision system confirmed its frayed condition.The unit also exhibited scratch marks, elongations, and fatigue lines¿types of damage typically resulting from contact with an unknown sharp object that caused mechanical stress.It is assumed that the distal tip was subjected to a force exceeding the material¿s yield strength prior to fraying.The same mechanical interaction likely contributed to the observed damage and the frayed condition of the device.Based on the available information and the evaluation of the returned device, the ¿catheter tip frayed/split/torn¿ was tip observed on the stent delivery system.Visual inspection and vision system analysis confirmed the presence of fraying, scratch marks, elongations, and fatigue lines localized at the distal tip.These characteristics are typical of damage resulting from contact with a sharp object or the application of force beyond the material's yield strength.The stent and clip remained properly mounted in their correct positions, and no other damage or abnormalities were found on the device.This suggests the condition likely occurred during preparation and or clinical use, potentially from interaction with another instrument or anatomical structure.Due to the absence of additional procedural details, the exact source of the mechanical stress could not be definitively identified.However, based on the type and location of the damage, it is most probable that the fraying was caused by unintended contact with a sharp object or excessive force applied during handling or insertion.According to the instructions for use, which is not intended as a mitigation of risk, ¿preparation of stent delivery system: a.Open the outer box to reveal the pouch containing the stent and delivery system.B.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.See warnings in section vi.C.After careful inspection of the pouch to look for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.D.Flush the delivery system with heparinized saline to expel air: attach a 3cc syringe filled with a heparinized saline to the luer hub.Apply positive pressure to the syringe until fluid weeps from the guidewire exit port.While covering the guidewire exit port with thumb and forefinger, apply positive pressure until saline weeps from the catheter tip and the space between the tip and the outer sheath.E.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.¿ the available information and product analysis do not indicate a design or manufacturing-related cause for the reported event.As a result, no corrective or preventive actions are warranted at this time.

• Brand Name: SMART RADIANZ
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 22344616
• Report Number: 9616099-2025-01027
• Device Sequence Number: 4825781
• Product Code: NIP
• UDI-Device Identifier: 20705032082676
• UDI-Public: (01)20705032082676(17)260531(10)18334985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: SR10060L
• Device Lot Number: 18334985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DEVICE; VASSALLO 18 FLOPPY
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian