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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During product analysis it was observed a device defect in the visual and the functional test.However in the electrical test the mini electro 3 didn't have any response.Therefore, the mini electrodes were microscopically reviewed and it was noted that the me1 and me3 had char residues, the me3 specifically was completely covered with these residues, the residues of me3 were carefully removed after this passed the test of electrical working properly.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).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
Reportable based on analysis completed on (b)(6) 2021.It was reported that during a ablation procedure involving a intellanav mifi xp, intracardiac electrogram(egm) noise was present during ablation that became more pronounced over time.Changing the catheter connection box did not resolve the issue.Changing the catheter resolved the issue.The procedure was completed, no patient complications were reported.Analysis of the device revealed magnetic electrodes 1 and 3 had char residues.

• 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
• MDR Report Key: 12556714
• Report Number: 2134265-2021-12314
• Device Sequence Number: 3488070
• Product Code: OAD
• UDI-Device Identifier: 08714729885726
• UDI-Public: 08714729885726
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 02/04/2024
• Device Model Number: 87048
• Device Catalogue Number: 87048
• Device Lot Number: 0026705820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1