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

Model Number D134301

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

Event Description

When the catheter was connected to the cable, there were noises on the display monitor.Trouble shooting was unsuccessful.The catheter was removed and a new catheter was used.No problem with the new catheter.No injury to the patient.

• Brand Name: LASSO NAV
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 6871775
• MDR Text Key: 86448143
• Report Number: 6871775
• Device Sequence Number: 1
• Product Code: DRF
• 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: 09/13/2017

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: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 17696237L
• 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: 09/13/2017
• Event Location: Other
• Date Report to Manufacturer: 09/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR