MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLATIP MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PM96200
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on analysis completed on 06-dec-2018.It was reported that temperature issues occurred.During an ablation procedure with a intellatip mifi open-irrigated catheter, ablation was performed without issue, but suddenly the temperature shown was above numerical value of 50 celsius to 60 celsius.The cable was replaced, but issue did not improve.The catheter was replaced with another mifi oi, there was no problem observed of the displayed temperature, and ablation was successfully completed.No patient complications were reported.However, analysis revealed fluid ingress under all ring 2 and 3 seals and both electrodes.Visual inspection shows dried body fluid found under both seals of rings 2 and 3, and under ring 2 and 3 electrodes.Dried body fluid also found on the handle, main body tubing and on the distal end.Dried saline found on the distal end and inside the irrigation ports.Electrical continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple 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.Connected device to a maestro 4000 to measure tip temperature.During 5 minutes at room temperature (22.6c), the maestro displayed 23c.After soaking 5 minutes in a tank of 37.0c saline, the maestro displayed 37c.Ablation was verified by using a maestro generator 4000, a metriq pump, and a tank of 37c saline solution.Through three ablations, the device performed normally with no temperature anomalies.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED
• 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: 8152169
• Report Number: 2134265-2018-63823
• Device Sequence Number: 19227396
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 07/26/2021
• Device Model Number: M004PM96200
• Device Catalogue Number: 86493
• Device Lot Number: 0022435929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• 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
• Patient Weight: 54