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 Codes	Failure to Deliver Energy (1211); 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
Event or Problem Description
It was reported that a temperature issue occurred.During an ablation procedure involving a intellatip mifi open irrigated catheter, the catheter was inserted into the body, and the physician tried to perform energization, but the temperature became 60 degrees celsius, and it was unable to perform energization.The issue was not resolved by replacing the cable.The issue was resolved by replacing the catheter.No patient complications were reported.However, returned device analysis revealed compromised ring 1, 2, and 3 electrode seals.Visual examination revealed dried body fluid is present on the shaft.There is dried saline on the handle and tip.The seals of all rings (r1, r2, r3) are compromised.Electrical continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box when the device was in the straight (neutral position).However, r3 was found open in both curve positions.The thermocouple measurement was within specification however is higher than what is typically seen on the bench.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.The ablation was verified by using the maestro generator 4000 and the metriq pump and the device was found within specifications.X-ray showed no obvious anomalies with ring 3.A couple of twists in the thermocouple wire were noted in the distal end.The distal section was dissected.Body fluid/corrosion is present under both ring 2 and ring 3 and both signal wires have ankle fractures at the weld.Signs of corrosion are present at the wire ends.Evidence of corrosion and body fluid is present inside the insulation.The handle was opened; no anomalies were noted during a microscopic visual inspection.

• 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: 8207925
• Report Number: 2134265-2018-64719
• Device Sequence Number: 1710105
• 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): 01/02/2019

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: M004PM96200
• Device Catalogue Number: 86493
• Device Lot Number: 0022317356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1