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

Model Number	87047
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure to treat atrial flutter a blazer ii xp catheter was selected for use.It was reported that the temperature reached 70 degrees celsius and it could not be controlled by the physician.The procedure was halted and the catheter was exchanged for another.The procedure was completed successfully without any patient complications.
Event or Problem Description
During an ablation procedure to treat atrial flutter a blazer ii xp catheter was selected for use.It was reported that the temperature reached 70 degrees celsius and it could not be controlled by the physician.The procedure was halted and the catheter was exchanged for another.The procedure was completed successfully without any patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes the reported observation of temperature higher than expected was not confirmed through investigational analysis.Visual examination revealed no visual defects.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.Electrical continuity testing revealed that the device was found within specification.No opens or shorts circuits were found.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED 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
• MDR Report Key: 11674154
• Report Number: 2134265-2021-04909
• Device Sequence Number: 3124727
• Product Code: OAD
• UDI-Device Identifier: 08714729452287
• UDI-Public: 08714729452287
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 12/02/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0026454567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1