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

Model Number D134301

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Event Description

Electrode 15 of the lasso catheter went bad/stopped relaying signals after the catheter was placed in the patient body.Lasso 2515 nav eco variable catheter.Catheter caused no harm to patient and is being returned to company for evaluation.

• Brand Name: LASSO NAV
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 7024770
• MDR Text Key: 91802765
• Report Number: 7024770
• 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: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 17680562L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1