MAUDE Adverse Event Report: CORDIS US. CORP BRITE TIP; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.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.
Event or Problem Description
As reported, the dilators of two 5f 11cm.035-inch brite tip sheath introducers fractured during insertion over the wire, and the complete ends of both dilators fell off.There was no reported patient injury.The dilator separated during insertion, with the hub breaking off outside the patient while the sheath was in place.The separated system was successfully removed over the wire.The device had been flushed prior to use, and the vessel dilator was properly snapped into place at the hub.No difficulties were encountered during the insertion process.The procedure was completed by carefully removing the device and inserting a 6f sheath.No damage was observed on the device before use, and no harm was caused to the patient.The vessel at the insertion site exhibited mild calcification and mild tortuosity.The devices will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, the dilators of two 5f 11cm.035-inch brite tip sheath introducers fractured during insertion over the wire, and the complete ends of both dilators fell off.There was no reported patient injury.The dilator separated during insertion, with the hub breaking off outside the patient while the sheath was in place.The separated system was successfully removed over the wire.The device had been flushed prior to use, and the vessel dilator was properly snapped into place at the hub.No difficulties were encountered during the insertion process.The procedure was completed by carefully removing the device and inserting a 6f sheath.No damage was observed on the device before use, and no harm was caused to the patient.The vessel at the insertion site exhibited mild calcification and mild tortuosity.Two non-sterile devices and three sterile devices were returned for analysis.One non- sterile device and the three sterile ones were evaluated under (b)(4) and the second non-sterile device was evaluated under (b)(4).(b)(4).Four si brite tip f5 11cm catheter units (one non-sterile and three sterile) were received and unpacked for analysis; the single non-sterile unit is the only device that exhibited a defect.Visual inspection of the non-sterile unit identified a separated condition on the vessel dilator at approximately 15.1 cm from the distal tip, while the three sterile units and other returned components showed no damage or anomalies on naked-eye inspection.Magnified imaging of the separation area revealed elongation of the plastic material and permanent plastic deformation consistent with a tensile-overload failure mechanism, indicating the material was subjected to excessive tensile forces prior to separation.Dimensional analysis of the vessel dilator (outer and inner diameters) was performed near the damaged area and the measurements were within specification.No evidence of manufacturing defects or assembly issues was identified, and the product analysis does not suggest the reported failure is related to the manufacturing process of the units.The reported ¿vessel dilator ¿ separated¿ was found on both non-sterile devices.The exact cause of the separation cannot be determined however, magnified image review of the separation area identified elongation of the plastic material and permanent plastic deformation, findings consistent with a tensile overload failure mechanism, indicating the material was subjected to excessive tensile forces prior to separation.Therefore, handling factors cannot be excluded.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), if increased resistance is felt upon insertion of the sheath, stop the procedure and use fluoroscopy to determine the cause.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the sheath.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 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: 23768398
• Report Number: 9616099-2025-01962
• Device Sequence Number: 16109919
• Product Code: DYB
• UDI-Device Identifier: 10705032000178
• UDI-Public: (01)10705032000178(17)280430(10)18450955
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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 Model Number: N/A
• Device Catalogue Number: 401511M
• Device Lot Number: 18450955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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.
• Patient Sex: Unknown