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

Model Number	87049
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter had char formation on the tip of the electrode.After an ablation procedure with an intellanav mifi xp, the catheter was removed from the body and the doctor noticed there was char formation on the tip of the electrode.The physician attributed this to the small indentation that is designed on the tip of the ablation catheter.The catheter was replaced for an oi mifi nav catheter.The procedure was completed successfully without any complications.
Event or Problem Description
It was reported the catheter had char formation on the tip of the electrode.After an ablation procedure with an intellanav mifi xp, the catheter was removed from the body and the doctor noticed there was char formation on the tip of the electrode.The physician attributed this to the small indentation that is designed on the tip of the ablation catheter.The catheter was replaced for an oi mifi nav catheter.The procedure was completed successfully without any complications.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed dried body fluid found on the handle, main body tubing, distal end.No other anomalies were observed.Electrical tests revealed that while manipulating the shaft, continuity checks revealed no electrical shorts or opens as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermistor resistances measured in spec and were typical.Functional inspection revealed 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.Rf ablation test revealed ablation was verified by using a maestro generator 4000 and load box.The device was found within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 8911224
• Report Number: 2134265-2019-09987
• Device Sequence Number: 1606751
• Product Code: OAD
• UDI-Device Identifier: 08714729885733
• UDI-Public: 08714729885733
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/07/2019

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: 02/10/2022
• Device Model Number: 87049
• Device Catalogue Number: 87049
• Device Lot Number: 0023326695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1