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

Model Number	67018000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of hypertension, and recent chest pain post coronary artery bypass graft was admitted for a cardiac catheterization.When the cordis vista brite tip 6f lcb 100cm vascular guide-catheter was removed from packaging, the tip was damaged.The cordis vascular guide-catheter was not used on the patient.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 12040592
• Report Number: 12040592
• Device Sequence Number: 17193177
• Product Code: DQY
• UDI-Device Identifier: 20705032020760
• UDI-Public: (01)20705032020760(17)240131(10)18000061
• 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): 06/15/2021
• Report Date (Section F): 06/15/2021

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: 67018000
• Device Catalogue Number: 67018000
• Device Lot Number: 18000061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 100
• Date Report Sent to FDA: 06/15/2021