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

Catalog Number	401623M
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	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the distal end of the sheath split and was split out of the box after opening a 6f 23 cm brite tip sheath introducer which was not used in the patient.There was no reported patient injury.The device was stored as per labeling and was opened in sterile field.Additional event details were requested; however, not provided.The device was returned for evaluation.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the distal end of the sheath split and was split out of the box after opening a 6f 23 cm brite tip sheath introducer which was not used in the patient.There was no reported patient injury.The device was stored as per labeling and was opened in sterile field.Additional event details were requested; however, not provided.A non-sterile unit of ¿si brite tip 6f 23cm str¿ was received for analysis.The parts included in the shipment were the cannula and the vessel dilator.All components were thoroughly inspected seeing that the cannula presents with one frayed/split/torn condition found approximately at 22.7 cm from the distal tip.No damages or anomalies were seen on the vessel dilator.Dimensional analysis was performed near the damages to verify the correct outer diameter (od) and inner diameter (id) of the cannula and found within specification.Visual inspection at high magnification showed the frayed/split/torn section at the distal tip of cannula.No other anomalies were seen during the microscopic examination.The reported ¿brite tip/distal tip-frayed/split/torn¿ was seen during the product evaluation.However, the exact cause of this damage cannot be determined.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ the product analysis did not provide evidence to suggest the failure was related to the manufacturing or design 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 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21468585
• Report Number: 9616099-2025-00305
• Device Sequence Number: 9182226
• Product Code: DYB
• UDI-Device Identifier: 10705032000246
• UDI-Public: (01)10705032000246(17)260731(10)18232369
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 07/31/2026
• Device Catalogue Number: 401623M
• Device Lot Number: 18232369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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.
• Patient Sex: Unknown