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

Model Number	67000400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease and hypertension and acute episode of nausea and dizziness.When performing a diagnostic heart cath, there was a nick seen out of the hub of the catheter.When it was touched, a piece of the hub fell off.Catheter not used on patients.

• Brand Name: CORDIS
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 11055192
• Report Number: 11055192
• Device Sequence Number: 16807309
• Product Code: DQO
• UDI-Device Identifier: 20705032019887
• UDI-Public: (01)20705032019887(17)230831(10)17970639
• 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): 12/17/2020
• Report Date (Section F): 12/17/2020

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: 17970639
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 64
• Date Report Sent to FDA: 12/17/2020