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

Model Number	67005400
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Nausea (1970)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with new onset of chest pain, nausea and shortness of breath.While having a diagnostic cath and stent replacement, the cordis xb 3.5 guide had a kink when pulled out of the packaging.Product not used on patient, no known harm.
Event or Problem Description
Elderly male with new onset of chest pain, nausea and shortness of breath.While having a diagnostic cath and stent replacement, the cordis xb 3.5 guide had a kink when pulled out of the packaging.Product not used on patient, no known harm.

• 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: 11138948
• Report Number: 11138948
• Device Sequence Number: 2946944
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: (01)20705032020166(17)280331(10)17972281
• 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,Followup
• Report Date (Section B): 01/06/2021
• Report Date (Section F): 01/06/2021

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: 17972281
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 01/06/2021