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

Model Number D134301

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Event Description

Sensor error upon catheter being connected via cable to biosense webster amplifier(piu).Catheter was introduced into the patient's body without any incidences or problems.Changed out this cath for another lasso with same lot# and sensor error repeated with 2nd lasso.Third lasso inserted with different lot# and 3rd cath working fine no problems noted.First and 2nd lasso caths (same lot #s) failed with sensor errors.No injury to the patient.Rep was notified.

• Brand Name: LASSO 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 6666711
• MDR Text Key: 78384754
• Report Number: 6666711
• 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: 06/21/2017

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: Physician
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 17650309L
• 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: 06/21/2017
• Event Location: Other
• Date Report to Manufacturer: 06/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• 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: 69 YR