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

Catalog Number	401511M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the head of the gray dilator of two 5f (11 cm).035-inch brite tip sheath introducers broke off.There was no reported patient injury.The devices were not inserted into the patient, and the tips broke off on the back table.Both devices were from the same lot number and were used during the same case.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, the head of the gray dilator of two 5f (11 cm).035-inch brite tip sheath introducers broke off.There was no reported patient injury.The devices were not inserted into the patient, and the tips broke off on the back table.Both devices were from the same lot number and were used during the same case.Per the account, additional information is not available.The devices were not returned for evaluation.The devices associated with both complaints have the same lot number.A product history record (phr) review of lot 18450955 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿vessel dilator ¿ separated¿ could not be substantiated for either device because the devices were not returned for evaluation and images were not provided.Based on a review of the device instructions for use (ifu), labeling includes general precautions related to device labeling and set-up; however, the reported vessel dilator head separation occurred on the back table prior to patient insertion, with no reported patient injury and limited additional information available.Therefore, the root cause of the reported event and the applicability of labeling to a specific failure mechanism could not be determined based on the information available at the time of review.Based on the available information, 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, 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: 23968241
• Report Number: 9616099-2026-00014
• Device Sequence Number: 4810096
• Product Code: DYB
• UDI-Device Identifier: 10705032000178
• UDI-Public: (01)10705032000178(17)280430(10)18450955
• 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): 02/26/2026

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: 401511M
• Device Lot Number: 18450955
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown