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	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reportable upon analysis.It was reported that a intellanav mifi open-irrigated during procedure for an atrial fibrillation, after approximately 30 minutes of ablation, radiofrequency (rf) delivery began to produce intermittent noise on the mifi electrodes.To solve the issue the device was replaced, and the procedure was completed without patient complications, the mapping system used was the hdx version 4.6, no error messages showed, the patient had an implantable device, which is not specified, and the failure did not occur near any specific anatomy.It was noted that the patient also had a resynchronization therapy pacemaker.The intellanav mifi open-irrigated catheter was returned for analysis.However, device analysis found that the device failed the flow test.The device was connected to a metriq pump and was purged at 60 ml/min.Irrigation ports did not flow freely since the device was obstructed due to the lumen was damaged by the kink in the shaft.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed that the device had bents in the distal section of the catheter.Functional test shows that the steering knob and the tension control knob functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The device's lumen was leak tested using an isaac hd leak tester (pressure decay test system) and a touhy burst 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 device was connected to a metriq pump and was purged at 60 ml/min.Irrigation ports did not flow freely since the device was obstructed due to the lumen was damaged by the kink in the shaft.A continuity test was performed, and the device was found within specifications.No open or shorts were detected.Electrical testing (catheter recognition / noise) showed that the device was recognized by rhythmia hdx system, but there were intermittent noise signals in baseline.An ablation test could not be performed because of the obstruction of the catheter.The device was destructively analyzed, and obstruction was found in the distal end with the bent/kink section.

• 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: 19102012
• Report Number: 2124215-2024-22474
• Device Sequence Number: 7858446
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: 08714729938385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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: 09/20/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0032478575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown