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

Model Number	M004PM9620N40
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on device analysis completed on 16jan2019.It was reported that the catheter was difficult to move/steer.During preparation for a myocardial ablation procedure for atrial flutter with an intellatip mifi oi ablation catheter, the bend lever was difficult to use because it was very hard.Even though an adjustment was made, it was still very hard and it was difficult to use.The procedure was performed using another lot of same device.No serious injury or adverse patient effects occurred.However, returned device analysis revealed fluid under ring 1 proximal seal and electrode.The device was returned for analysis.Dried, rust colored fluid was under ring 1 proximal seal and electrode.Dried body fluid found on the handle, main body and distal end.Dried saline found on the distal end and inside the irrigation ports.Tip motion was evaluated against a curve template.Both curves reached the specified template area.The steering knob and tension control knob functioned properly on both lock and unlock positions, however both knobs required abnormal effort to rotate.X-ray found no anomalies.The steering and tension knobs were removed to inspect the o-rings.Each o-ring appeared normal and lubricant was found on both sides of each ring.The handle hub area and both knobs also appeared normal.Steering knob o-ring measurements were typical.Tension knob o-ring measurements were typical.The distal end was dissected to investigate possible fluid ingress at ring 1.Dried fluid/corrosion found under ring 1, but none was found under rings 2 and 3.The distal end cavity was free of dried fluid/corrosion except directly under ring 1.

• 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: 8333103
• Report Number: 2134265-2019-01137
• Device Sequence Number: 19079033
• Product Code: OAD
• UDI-Device Identifier: 08714729848707
• UDI-Public: 08714729848707
• 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): 02/12/2019

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: 05/08/2020
• Device Model Number: M004PM9620N40
• Device Catalogue Number: 86493
• Device Lot Number: 0020622763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1