MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problems Pacing Problem (1439); Defective Component (2292); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Event Description

During the electrophysiology procedure today, we attempted to pace the heart for diagnostic purposes, but a message will come to the ge system "stim connection not valid." we started to troubleshoot the problem.Called ge system representative for help, and it looks like it was a bad fiber optic cable (this is a brand-new system, we have used it only twice) we replaced the fiber optic cable, and the message stopped appearing on the ge system, but at that moment, carto system stopped communicating to the micropace stimulator.We still were not able to pace for the procedure.We had to bypass carto connections to be able to pace only through the micropace and it worked.The duration of this troubleshooting lasted about 45 min, and the patient was stable under anesthesia during all this time.Cable changed, connection was not adequate once restarted, the system case was able to proceed.We have communicated with ge and biosense webster to prevent future cable disruptions and improve restart process.Biomed replaced fiber that connects cardiolab to amplifier, reset ge cardiolab; unit was unable to pace at this point because it wasn't communicating with biosense webster carto 3.Carto 3 was bypassed and reconfigured by biosense webster service tech.Device returned to service.

• Brand Name: CARTO 3
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 8964374
• MDR Text Key: 156580869
• Report Number: 8964374
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1460 DA