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

Catalog Number	401611M
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	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 6f 11cm brite tip sheath introducer was used.However, it could not be inserted.When it was removed, the tip of the sheath was frayed.Therefore, it was replaced with a new device and the procedure was continued.There was no reported injury to the patient.This was an evt case.After the right femoral puncture, the brite tip sheath was used.After evt was completed, it was confirmed that there were no complications at the puncture site.Additional information was requested; however, the information could not be obtained.The reported ¿brite tip/distal tip frayed/split/torn and catheter sheath introducer (csi) insertion difficulty¿ could not be confirmed as the device was not returned for analysis and images were not provided.The exact cause could not be determined.Factors such as vessel anatomy, user handling, and concomitant devices could be a contributing factor additional force and manipulation of the catheter sheath introducer (csi) while attempting to insert in the vessel may have also been a contributing factor for the reported event.Vessel characteristics, such as acute/severe angles/tortuosity may also contribute to such event, as these can lead to resistance upon insertion and cause buckling of the sheath material.As per the instructions for use (ifu), during insertion of the sheath, it should be grasped close to the skin to prevent buckling.To avoid damage to the sheath tip, do not withdraw the dilator until the csi is in vessel.Hold the sheath in place when inserting, positioning, or removing any catheters.The information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
As reported, the 6f 11cm brite tip sheath introducer was used.However, it could not be inserted.When it was removed, the tip of the sheath was frayed.Therefore, it was replaced with a new device and the procedure was continued.There was no reported injury to the patient.This was an evt case.After the right femoral puncture, the brite tip sheath was used.After evt was completed, it was confirmed that there were no complications at the puncture site.The device will not be returned for evaluation.Additional information was requested; however, the information could not be obtained.

• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 20631029
• Report Number: 9616099-2024-00367
• Device Sequence Number: 8038906
• Product Code: DYB
• UDI-Device Identifier: 10705032000239
• UDI-Public: (01)10705032000239(17)261130(17)18267502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/07/2024

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 Catalogue Number: 401611M
• Device Lot Number: 18267502
• 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: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 12/13/2023
• 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: ANOTHER DEVICE
• Patient Sex: Unknown