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

Model Number	687280110
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	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the 110cm brite tip radianz was being delivered to a lesion but the distal end got frayed.The device will not be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18116285 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the 110cm brite tip radianz was being delivered to a lesion, but the distal end got frayed.The product was not returned for analysis.A product history record (phr) review of lot revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed.Factors such as exposure calcified plaque or attempting to advance the device against resistance may have contributed to the reported event.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, ¿avoid the use of the brite tip radianz¿ guiding sheath in vasculature with extreme tortuosity, calcified plaque or thrombus.If resistance is felt upon insertion or withdrawal, investigate the cause before continuing¿ based on the information available and the phr review, there is no indication that 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 110cm brite tip radianz was being delivered to a lesion but the distal end got frayed.The device will not be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

• Brand Name: BRITE TIP RADIANZ
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes
• 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: 17107811
• Report Number: 9616099-2023-06517
• Device Sequence Number: 14015712
• Product Code: DYB
• UDI-Device Identifier: 20705032081228
• UDI-Public: (01)20705032081228(17)240531(10)18116285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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 Expiration Date: 05/31/2024
• Device Model Number: 687280110
• Device Catalogue Number: 687280110
• Device Lot Number: 18116285
• 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
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2022
• 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