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

Model Number	67005400
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of hypertension and coronary artery disease was presented with new onset of chest pain.Patient was admitted to the cardiac catheterization lab for a stent placement and angioplasty.When examining the cordis vista brite tip® guiding catheter, there was a kink in the curve of the guide.Product not used on a patient.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 1820 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 12452533
• Report Number: 12452533
• Device Sequence Number: 3964237
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: (01)20705032020166(17)240531(10)18027482
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/30/2021
• Report Date (Section F): 08/30/2021

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 Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 18027482
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 139
• Date Report Sent to FDA: 08/30/2021