MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D134302

Device Problems Out-Of-Box Failure (2311); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

Lasso catheter set up prior to start of case, magnetic sensor showed error message on mapping system.Cable changed without resolution.Catheter had to be changed out, the new catheter sensed as it should, procedure completed successfully.No apparent visual defects noted.Device failed out of the box.This is the fourth similar event with this type of equipment over a period of approximately 3 months.Product has been returned to the manufacturer.It is unknown what is causing or contributing to these problems.

• Brand Name: LASSO 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 3333 diamond canyon road; diamond bar CA 91765
• MDR Report Key: 4168815
• MDR Text Key: 4868521
• Report Number: 4168815
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/08/2014

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: Physician
• Device Catalogue Number: D134302
• Device Lot Number: 16089647L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2014
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 91