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	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an ablation procedure in the cavotricuspid isthmus (cti), the intellanav mifi xp catheter was pulled back from the inferior vena cava (ivc) and a steam pop was felt.Moving to a different location the catheter did not have a noticeable change in effectiveness or impedance.The catheter was placed in the same position as before, and another steam pop was felt.The procedure was completed without any patient complications.The catheter is expected to be returned for analysis.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection revealed clotting/charring in the distal section of the catheter shaft, between the tip and ring #1.Functional testing noted no abnormal resistance while maneuvering the catheter.Electrical and continuity tests were performed, and the device showed all results were within specifications.Additional testing was performed, the device was able to complete an ablation without any difficulties.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
Event or Problem Description
It was reported that during an ablation procedure in the cavotricuspid isthmus (cti), the intellanav mifi xp catheter was pulled back from the inferior vena cava (ivc) and a steam pop was felt.Moving to a different location the catheter did not have a noticeable change in effectiveness or impedance.The catheter was placed in the same position as before, and another steam pop was felt.The procedure was completed without any patient complications.The catheter has been returned for analysis.

• Brand Name: INTELLANAV MIFI XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14106741
• Report Number: 2134265-2022-04365
• Device Sequence Number: 20439991
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 02/09/2025
• Device Model Number: 87048
• Device Catalogue Number: 87048
• Device Lot Number: 0028838339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female