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

Catalog Number	6700820E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
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 6f.070 jr4 vista brite tip catheter was collapsed/leaking.There was no reported injury to the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the 6f.070 jr4 vista brite tip catheter collapsed/leaking.There was no reported injury to the patient.The device was not returned for evaluation.A product history record (phr) review of lot 18516164 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ leakage and catheter (body/shaft) ¿ damaged¿ could not be substantiated because the device was not returned and images were not provided.A review of the device labeling did not identify a directly relevant statement that could be applied based on the limited available information, and use-related factors cannot be excluded.Based on the available information, there is no indication that this event is related to the manufacturing or design process; therefore, no further actions will be taken.
Event or Problem Description
As reported, the 6f.070 jr4 vista brite tip catheter was collapsed/leaking.There was no reported injury to the patient.The device will be returned for evaluation.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• 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 ; 7863138372
• MDR Report Key: 24483831
• Report Number: 9616099-2026-00330
• Device Sequence Number: 13431040
• Product Code: DQY
• UDI-Device Identifier: 10705032020442
• UDI-Public: (01)10705032020442(17)280930(10)18516164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• 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): 04/03/2026

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
• Device Catalogue Number: 6700820E
• Device Lot Number: 18516164
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown