MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 EP NAVIGATION SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 10439011

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/10/2016

Event Type  malfunction  

Event Description

Poor signal during procedure.When the catheter was connected, the image on the display was poor.The catheter was removed, and a new catheter was used.The new catheter worked fine with clear image.No injury to the patient.

• Brand Name: CARTO 3 EP NAVIGATION SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy; irwindale, CA 91706
• MDR Report Key: 5837126
• MDR Text Key: 50883189
• Report Number: 5837126
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2016

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: No Information
• Device Model Number: 10439011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Event Location: Other
• Date Report to Manufacturer: 07/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR