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

Catalog Number	401511M
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	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a 5f 11cm brite tip catheter sheath introducer (csi) was damaged during the puncture of the artery.An unknown csi was used as a replacement.There were no reported injuries to the patient.Additional information was requested but was not provided.The device is now being returned.Addendum: the brite tip csi was returned with the distal tip frayed/torn.
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: complaint conclusion: as reported, the tip of a 5f 11cm brite tip catheter sheath introducer (csi) was damaged during the puncture of the artery.An unknown csi was used as a replacement.There were no reported injuries to the patient.Additional information was requested but was not provided.The device is now being returned.A non-sterile catheter unit (si brite tip f5 11cm) was received for evaluation with the sheath, vessel dilator, and mini guidewire included.The sheath had a torn distal tip, and the mini guidewire was kinked/bent at the distal end.Microscopic analysis of the torn sheath revealed surface scratches, micro-elongations, edge discoloration, and plastic deformation, consistent with mechanical stress likely from sharp objects or tensile forces.The malfunction ¿brite tip/distal tip-frayed/split/torn¿ was observed during product analysis.The exact cause of the damages cannot be determined, however, mechanical stress from a sharp object or tensile forces are likely contributing factors.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 of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿thread the csi/dilator assembly over the guidewire, grasping the sheath close to the skin to prevent buckling.Using a rotating motion, advance the assembly through the tissue and into the vessel.If increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21993369
• Report Number: 9616099-2025-00786
• Device Sequence Number: 4311975
• Product Code: DYB
• UDI-Device Identifier: 10705032000178
• UDI-Public: (01)10705032000178(17)251231(10)18176678
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• 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): 06/19/2025

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: 12/31/2025
• Device Catalogue Number: 401511M
• Device Lot Number: 18176678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/14/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CSI
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic