MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS; CATHETER, PERCUTANEOUS

Model Number	67003400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of type 1 db (diabetes), cad (coronary artery disease) and recent sob (shortness of breath) and edema.Procedure: diagnostic heart cath and pci (percutaneous coronary intervention).2 kinks were visualized in the cordis, vista britetip catheter.Not used on patient.
Event or Problem Description
Elderly female with history of type 1 db (diabetes), cad (coronary artery disease) and recent sob (shortness of breath) and edema.Procedure: diagnostic heart cath and pci (percutaneous coronary intervention).2 kinks were visualized in the cordis, vista britetip catheter.Not used on patient.

• Brand Name: CORDIS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 17134811
• Report Number: 17134811
• Device Sequence Number: 15064887
• Product Code: DQY
• UDI-Device Identifier: 20705032020036
• UDI-Public: (01)20705032020036(17)280228(10)18190419
• 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): 05/22/2023
• Report Date (Section F): 05/22/2023

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: 67003400
• Device Catalogue Number: 67003400
• Device Lot Number: 18190419
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 06/15/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 05/22/2023