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

Model Number	M004MR4500K20
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 06dec2018.It was reported that catheter image on the rhythmia mapping screen started moving around sporadically and then disappeared.However, analysis revealed body fluid ingress via ring 3 seals and electrode could have caused intermittent tracking that was observed during the procedure.Visual inspection shows dried body fluid found under both ring 3 seals and electrode.Dried body fluid also found on the handle, main body tubing and distal end.Dried saline found on the distal end and inside the irrigation ports.
Additional Manufacturer Narrative
Describe event or problem updated to include additional analysis details.Model number corrected from 87048 to m004mr4500k20.Initial reporter first name corrected from (b)(6) to (b)(6).Initial reporter last name corrected from (b)(6) to (b)(6).Occupation corrected from other health care professional to physician.(b)(4).
Event or Problem Description
Reportable based on analysis completed on 06dec2018.It was reported that tracking issues occurred.During a left atrial flutter procedure the intellanav mifi xp catheter image on the rhythmia mapping screen started moving around sporadically and then disappeared.The procedure was completed with another intellanav mifi xp catheter.No patient complications were reported.However, analysis revealed body fluid ingress via ring 3 seals.Visual inspection shows dried body fluid found under both ring 3 seals and electrode.Dried body fluid also found on the handle, main body tubing and distal end.Dried saline found on the distal end and inside the irrigation ports.Electrical continuity checks revealed no electrical shorts, as checked manually using a multi-meter and breakout box.Rings 2 & 3 measured electrically open.All other electrodes, sensor 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 evidence of dried fluid throughout the distal end cavity.Rings 2 & 3 were removed.Dried body fluid found under both electrodes and inside the feed through holes.Both ring wires are broken at the ankle to the electrode weld.

• 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: 8149211
• Report Number: 2134265-2018-63826
• Device Sequence Number: 19207933
• Product Code: OAD
• UDI-Device Identifier: 08714729885726
• UDI-Public: 08714729885726
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• 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: 06/25/2021
• Device Model Number: M004MR4500K20
• Device Catalogue Number: 87048
• Device Lot Number: 0022304555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Patient Age: 69 YR