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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a procedure to treat redo atrial flutter and atrial fibrillation, a intellanav mifi open-irrigated catheter was high flow flushed (60ml/min).The physician was unhappy with the flow out of the irrigation ports.Only one of the ports was spraying in a jet and the rest either were blocked or just bubbling slowly.Building pressure with the stopcock closed was performed while priming the pump but were unable to change the results, no error messages were displayed.The catheter was exchanged to solve the issue and the procedure was successfully completed with no patient complications.Device is expected to be returned.
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.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Per visual inspection the device didn't present any visual defected for this reason the visual inspection pass.Functional test was passed as 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.Unit passed the leakage test without any problems.All six irrigation ports flow freely on flow test.The pump was programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.
Event or Problem Description
It was reported that during preparation for a procedure to treat redo atrial flutter and atrial fibrillation, a intellanav mifi open-irrigated catheter was high flow flushed (60ml/min).The physician was unhappy with the flow out of the irrigation ports.Only one of the ports was spraying in a jet and the rest either were blocked or just bubbling slowly.Building pressure with the stopcock closed was performed while priming the pump but were unable to change the results, no error messages were displayed.The catheter was exchanged to solve the issue and the procedure was successfully completed with no patient complications.Device has been returned.

• 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: 15044107
• Report Number: 2124215-2022-26133
• Device Sequence Number: 14727987
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/06/2022

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: 08/16/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0027844197
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 65 KG