MAUDE Adverse Event Report: CORDIS; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	67000000
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Chest Pain (1776)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of coronary artery disease, transcatheter aortic valve replacement in 2015 and recent chest pain and atrial fibrillation was admitted for a heart catheterization with percutaneous intervention.The cordis judkins left 3 6f guiding catheter had a kink in it, visible inside the packaging.The cordis judkins left 3 6f guiding catheter was removed from cardboard and kink remained.Device was not used on the patient.

• Brand Name: CORDIS
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12165893
• Report Number: 12165893
• Device Sequence Number: 19059780
• Product Code: DQO
• UDI-Device Identifier: 20705032019856
• UDI-Public: (01)20705032019856(17)230228(10)17936172
• 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): 07/02/2021
• Report Date (Section F): 07/02/2021

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: 67000000
• Device Catalogue Number: 67000000
• Device Lot Number: 17936172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 78
• Date Report Sent to FDA: 07/02/2021