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

Model Number	87051
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The intellanav mifi catheter was selected for use during the ablation procedure to treat atypical flutter.It was reported that catheter was ineffective with ablation.There was no temperature increase.The ablate from catheter had no effect on 20 ablation points.The catheter was removed from the body and replaced with a new one from the same model.Ablation was performed on the same position and was effective.The procedure was completed succesfully without patient complications.The device is expected to be returned for analysis.
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
The intellanav mifi catheter was selected for use during the ablation procedure to treat atypical flutter.It was reported that catheter was ineffective with ablation.There was no temperature increase.The ablate from catheter had no effect.The catheter was removed from the body and replaced with a new one from the same model.Ablation was performed on the same position and was effective.The procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed that the device did not have visual defects.Functional test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The continuity test was performed, and the device was found within specifications.No shorts or opens were detected.The ablation was verified by using the maestro generator 4000 and metriq, and the device was found within specifications.

• Brand Name: INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER
• 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: 18345104
• Report Number: 2124215-2023-71521
• Device Sequence Number: 5380687
• Product Code: OAD
• UDI-Device Identifier: 08714729885719
• UDI-Public: 08714729885719
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: 05/30/2026
• Device Model Number: 87051
• Device Catalogue Number: 87051
• Device Lot Number: 0031727334
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown