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

Model Number LASSO 2515

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

Poles 13-14 intermittently experienced a square wave pattern over intracardiac signals, physician continued to use device.This was a catheter sensor or connection issue.It was a lasso mapping catheter, which contains 20 poles.There were 2 poles not function properly.The physician used other 18 poles to complete the case.No injury to the patient.

• Brand Name: LASSO DEFLECTABLE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 3333 diamond canyon rd; diamond bar CA 91765
• MDR Report Key: 5731922
• MDR Text Key: 47600771
• Report Number: 5731922
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LASSO 2515
• Device Catalogue Number: D134301
• Device Lot Number: 17443380L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2016
• Event Location: Other
• Date Report to Manufacturer: 06/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR