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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
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 january 8, 2019.An intellatip mifi oi ablation catheter was selected for using during an atrial fibrillation ablation procedure.It was reported that after the catheter was inserted, all potentials could not be found; it seemed that electrical loss occurred.The catheter was replaced and the procedure was performed without further issues.However, returned device analysis found obstructed irrigation ports.The obstruction was suspected to be dried saline; however, the obstruction had not been located during analysis.During returned device analysis, the device passed all electrical testing.There were no electrical shorts or opens; all electrodes, sensor, and thermocouple resistance measurements were within specification.The steering knob and tension control knob functioned properly on both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Ablation was attempted; however, an "occlusion detected" error occurred immediately after the pump was started.Ablation was performed on the bench without irrigation connected, and the device was found within specification.The handle was cut open to inspect for irrigation leaks; no evidence of leaks was found.A syringe filled with water was then connected to the luer fitting.While applying pressure to the plunger, due to an obstruction in the lumen somewhere along its length, no fluid leaked into the handle cavity or exited the irrigation ports at the distal end.Water was injected into each lumen channel while removing sections of lumen along the entire length or the shaft; the obstruction was isolated to the distal end/tip; however, the obstruction could not be located during analysis.

• 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: 8293707
• Report Number: 2134265-2019-00645
• Device Sequence Number: 13957690
• 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): 01/31/2019

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: 07/12/2021
• Device Model Number: M004PM96200
• Device Catalogue Number: 86493
• Device Lot Number: 0022371866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1
• Patient Weight: 70