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

Model Number	87048
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that episodes of char on the catheter occurred.During an ablation procedure to treat flutter with a intellanav mifi xp catheter, the physician started at 70 watts, 70 degrees temp and then increased to 90 watts.They were getting 90 watts and temperatures in the 50s with no impedance rise.When the physician was ablating, they had an episode of char on the catheter.The tip was cleaned and they went back down to 80 watts or so (lower powers were recommended).The temperature set point was 70 degrees.However, they went back to 90 watts because the physician wasn't getting block.They finally got block on this last radiofrequency (rf) burn, but when he pulled the catheter out it had char a second time.The physician attributed the char to high watts being used.A non-boston scientific steerable sheath was used.The procedure was completed successfully.

• 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: 9410471
• Report Number: 2134265-2019-14909
• Device Sequence Number: 16877543
• Product Code: OAD
• UDI-Device Identifier: 08714729885726
• UDI-Public: 08714729885726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/04/2019

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 Model Number: 87048
• Device Catalogue Number: 87048
• Device Lot Number: 0024389093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1
• Patient Weight: 91