MAUDE Adverse Event Report: CORDIS CORPORATION BRITE TIP RADIANZ; INTRODUCER, CATHETER

Catalog Number	687280135
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	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the insertion of the 6f 135cm brite tip radianz guiding sheath at the superficial femoral artery (sfa) via radial approach was difficult and the tip became frayed.A 6f 110cm brite tip radianz guiding sheath was used instead.Insertion was successful and the procedure continued.There were no reports of patient injury.No additional information was able to be obtained.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the insertion of the 6f 135cm brite tip radianz guiding sheath at the superficial femoral artery (sfa) via radial approach was difficult and the tip became frayed.A 6f 110cm brite tip radianz guiding sheath was used instead.Insertion was successful and the procedure continued.There were no reports of patient injury.No additional information was able to be obtained.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18336971 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿catheter sheath introducer (csi) insertion difficulty and brite tip/distal tip frayed/split/torn¿ could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.It is possible that attempting to advance the device against resistance may have contributed to the frayed condition that then occurred.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿avoid the use of the brite tip radianz¿ guiding sheath in vasculature with extreme tortuosity, calcified plaque or thrombus.If resistance is felt upon insertion or withdrawal, investigate the cause before continuing¿ based on the information available for review, there is no indication to suggest that the reported incident could be related to the design or manufacturing process of the units.No preventative or corrective actions will be taken at this time.

• Brand Name: BRITE TIP RADIANZ
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 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: 22516563
• Report Number: 9616099-2025-01124
• Device Sequence Number: 20821197
• Product Code: DYB
• UDI-Device Identifier: 20705032081211
• UDI-Public: (01)20705032081211(17)260630(10)18336971
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 687280135
• Device Lot Number: 18336971
• Was Device Available for Evaluation?: No
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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
• Patient Sex: Unknown