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

Model Number 67000000

Device Problem Material Deformation (2976)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776)

Event Date 06/29/2021

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 12165893
• MDR Text Key: 261485033
• Report Number: 12165893
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032019856
• UDI-Public: (01)20705032019856(17)230228(10)17936172
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA
• Patient Weight: 78