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

Model Number 67000400

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Event Description

Elderly male with history of coronary artery disease, diabetes and recent shortness of breath.Procedure is staged percutaneous coronary intervention.When the package was open and device was inspected, there were 2 kinks in separate areas of the tubing.Product not used, another device was obtained for the procedure.

• 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: 11257792
• MDR Text Key: 229655790
• Report Number: 11257792
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032019887
• UDI-Public: (01)20705032019887(17)280831(10)17969147
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 67000400
• Device Catalogue Number: 67000400
• Device Lot Number: 17969147
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 70