MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004MR45000
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 06-dec-2018.It was reported that the magnetic sensor failed.During an atypical flutter ablation procedure with an intellanav mifi xp catheter was used.It was reported that towards the end of the case, they were getting ready to finish up, got a few more ablations to deliver and the magnetic sensor in the catheter broke.They were able to track it through impedance tracking without using the magnetic sensor.No patient complications were reported.However, analysis revealed fluid ingress into distal end cavity via ring 3 seals.Visual inspection shows dried body fluid under both ring 3 seals and electrode.Dried body fluid found on the handle, main body tubing and distal end.Electrical continuity checks revealed no electrical shorts, as checked manually using a multi-meter and breakout box.The mag sensor measured electrically open in straight, right and left curve configurations.All electrodes and thermistor resistances measured in spec and were typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.X-ray found no anomalies.The ring electrodes were removed.Dried body fluid found under ring 3 electrode and inside the feed-through hole.The distal end was opened.Dried body and saline fluid found throughout the distal end cavity.The magnetic sensor wires were isolated at approximately 40mm from the end of the distal tip.Resistance measurements through the sensor wires back to the handle were typical.Resistance through the sensor was open o.The sensor assembly was dissected.A sensor wire was found broken near the twisted wire pair solder joint.

• Brand Name: INTELLANAV MIFI XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8151890
• Report Number: 2134265-2018-63829
• Device Sequence Number: 16210263
• Product Code: OAD
• UDI-Device Identifier: 08714729885719
• UDI-Public: 08714729885719
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: M004MR45000
• Device Catalogue Number: 87051
• Device Lot Number: 0022319970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1