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

Model Number	67003600
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of diabetes and coronary artery disease that came in for elective percutaneous coronary intervention.When the package was opened, there was a kink, bend in the tubing.Device was not used, a new one obtained.No harm to the 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: 10626304
• Report Number: 10626304
• Device Sequence Number: 2630573
• Product Code: DQY
• UDI-Device Identifier: 20705032020050
• UDI-Public: (01)20705032020050(17)230630(10)17957088
• 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): 09/23/2020
• Report Date (Section F): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 67003600
• Device Catalogue Number: 67003600
• Device Lot Number: 17957088
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 135
• Date Report Sent to FDA: 09/23/2020