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

Model Number D7L1020CT

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Catheter was placed near the pulmonary veins, catheter hooked up to mapping system, pole 2-3 not functioning.Cable changed, to no avail, catheter ports changed to no avail.Product non functional.Removed from field and changed out for a new product.This facility has had three reports of similar events with this type of device over the last two months.The cause of the failure is unknown.The manufacturer has been notified and product is being returned to them for their evaluation.

• Brand Name: LASSO
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 3333diamond canyon road; diamond bar CA 91765
• MDR Report Key: 3738049
• MDR Text Key: 4278327
• Report Number: 3738049
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: D7L1020CT
• Device Lot Number: 15980397L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR