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

Model Number	67000400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease and hypertension.Presented for diagnostic heart catheterization; when the jl 4 guide catheter was removed from packaging, it was kinked in 2 areas.Product 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: 10851146
• Report Number: 10851146
• Device Sequence Number: 11567474
• Product Code: DQY
• UDI-Device Identifier: 20705032019887
• UDI-Public: (01)20705032019887(17)280731(10)17982977
• 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): 11/13/2020
• Report Date (Section F): 11/13/2020

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: 67000400
• Device Catalogue Number: 67000400
• Device Lot Number: 17982977
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1
• Patient Weight: 93
• Date Report Sent to FDA: 11/13/2020