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

Catalog Number	401690M
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the distal end of a 6f 90cm si brite tip catheter sheath introducer was found broken/damaged upon opening.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The si brite tip f9 90cm device was received non-sterile inside a transparent plastic bag and was unpacked for product evaluation, which included the obturator, the bts csi, and the winged storage tube.The brite tip of the bts csi was observed to be frayed, and the obturator exhibited a kinked condition located approximately 67 cm from the distal tip; the winged storage tube was inserted into the obturator with no visible damage, and no other notable details were observed.As the product catalog does not include obturator or winged storage tube specifications, dimensional analysis was performed to verify the correct outer diameter of the obturator, with measurements taken near the kinked area, and the obturator was found to be within specification.Visual system inspection of the brite tip identified scratch marks, elongations, and fatigue lines, which are characteristic of mechanical damage caused by interaction with an unknown sharp object; these findings indicate the brite tip was subjected to a force exceeding the material yield strength prior to fraying, and the same factors could have contributed to the frayed condition observed upon receipt.Further visual inspection of the bts csi brite tip confirmed the presence of scratch marks, elongations, and fatigue lines, and the product analysis did not provide evidence to suggest the observed damage is related to the device design or manufacturing process; therefore, no preventive or corrective actions are warranted at this time.The reported ¿brite tip / distal tip ¿ frayed / split / torn¿ was seen during the product evaluation however, the exact cause of these damages cannot be determined.Magnified images presented evidence of mechanical damage caused by interaction with an unknown sharp object 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 product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿do not introduce sharp medical instruments which can lead to device damage.¿ 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.
Event or Problem Description
As reported, the distal end of a 6f 90cm si brite tip catheter sheath introducer was found broken/damaged upon opening.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was returned for evaluation.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 23957453
• Report Number: 9616099-2026-00010
• Device Sequence Number: 12164947
• Product Code: DYB
• UDI-Device Identifier: 10705032000284
• UDI-Public: (01)10705032000284(17)280331(10)18439911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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 Catalogue Number: 401690M
• Device Lot Number: 18439911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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
• Patient Sex: Unknown