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	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
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 open-irrigated was selected for use during the procedure to treat intratrioventricular reentrant tachycardia.It was reported that during the catheter preparation it was observed that the catheter irrigation would not flow through.They attempted to use a pump for continuous flush as well as a hand injection, but both were ineffective.It was suspected that the catheter interior was blocked.No damages were noted.A different device was used for the procedure.It was completed successfully without patient complications.The device is expected to be returned for analysis.
Event or Problem Description
The intellanav mifi open-irrigated was selected for use during the procedure to treat intratrioventricular reentrant tachycardia.It was reported that during the catheter preparation it was observed that the catheter irrigation would not flow through.They attempted to use a pump for continuous flush as well as a hand injection, but both were ineffective.It was suspected that the catheter interior was blocked.No damages were noted.A different device was used for the procedure.It 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 testing showed 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 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 device was connected to a metriq pump and was purged at 60 ml/min.All six irrigation ports flow freely.The pump was programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.The device was destructively analyzed and no damaged was found, no other issues were identified on the internals components of the device.Therefore, since no damages were found on the returned device and there is no evidence enough, it is determined that the most probable cause cannot be confirmed due to the lack of information.

• 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: 18751611
• Report Number: 2124215-2024-06676
• Device Sequence Number: 3740549
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 11/22/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030593913
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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