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

Model Number 67000400

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 12/10/2020

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 11055192
• MDR Text Key: 223135268
• Report Number: 11055192
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032019887
• UDI-Public: (01)20705032019887(17)230831(10)17970639
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 67000400
• Device Catalogue Number: 67000400
• Device Lot Number: 17970639
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Weight: 64