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

Model Number	87047
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Intellanav mifi open-irrigated was evaluated by boston scientific.Visual inspection did not note any defects.Functional test was performed, 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.The device lumen was leak tested using an isaac hd leak tester (pressure decay test system) and a touhy bourst seal for sealing the irrigation holes and mini electrodes.The lumen pressure decay was measured three times.The unit passed the test without problems.The continuity test was performed and no problems were detected.Then, the device was connected to a metriq pump and was purged at 60 ml/min, and it was observed that it was obstructed.The device was connected and recognized by the rhythmia hdx and maestro 4000, no noise baseline issues were observed.The noise test during ablation could not be performed because the flow test fails due it was obstructed.During the dissection analysis a kink on the pair sensor wires and a insolation damage on the guidecoil at the same distance.Is important to mention that no damages were observed on the irrigation system that could have contributed to the obstruction issue.Laboratory analysis was able to confirm the reported observation of noise as a cause traced to device design.However, laboratory analysis was unable to confirm the cause of the obstruction issue as no damages were observed on the irrigation system that could have contributed to the obstruction issue.
Event or Problem Description
The complaint is reportable for malfunction per product investigation results; it was reported that there was a significant microelectrode signal interference.During a procedure to treat supraventricular tachycardia (svt) an intellanav mifi open-irrigated catheter was selected for use.It was noted that there was significant microelectrode signal interference in electrodes 1-2.The noise did not improve over the duration of the ablation, with repeat ablations, or with pacing.No error messages displayed.The device was replaced, and the procedure was completed successfully without patient complications.The catheter was returned to boston scientific for laboratory analysis.Upon device analysis, it was found during the flow test that the device was occluded.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• 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: 18130046
• Report Number: 2124215-2023-63222
• Device Sequence Number: 12400393
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P150005/S017
• 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
• Report Date (Section B): 11/14/2023

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: 08/17/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0029977007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown