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	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient irrigation flow from catheter tip was observed during preparation of the catheter.The intellanav mifi open-irrigated was selected for use during the procedure to treat supraventricular tachycardia.The catheter was connected to the metriq pump and flushed at 60ml/min and it was observed that the shower pattern at the irrigation ports was absent, and it appeared to be a consistent drip.Scrub nurse switched to a syringe to attempt a temporary manual flush then observed a proper irrigation.The catheter was switched back to metriq pump for irrigation and poor irrigation was again observed.Catheter was replaced for a new one to begin procedure, which irrigated properly.No patient complications occurred.The device is expected to be returned for analysis.
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 intellanav mifi open-irrigated catheter was returned to boston scientific for analysis.Visual inspection did not find any defects.Functional test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.However, further analysis of the device found device had a gross leak during the leakage test.Additionally, irrigation could not be completed when device was connected to a metriq pump for a flow test.The message of occlusion appeared in the pump display.When the device was destructively analyzed, a leak on the joint of the dual lumen with the extension tube was observed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
Event or Problem Description
It was reported that insufficient irrigation flow from catheter tip was observed during preparation of the catheter.The intellanav mifi open-irrigated was selected for use during the procedure to treat supraventricular tachycardia.The catheter was connected to the metriq pump and flushed at 60ml/min and it was observed that the shower pattern at the irrigation ports was absent, and it appeared to be a consistent drip.Scrub nurse switched to a syringe to attempt a temporary manual flush then observed a proper irrigation.The catheter was switched back to metriq pump for irrigation and poor irrigation was again observed.Catheter was replaced for a new one to begin procedure, which irrigated properly.No patient complications occurred.The device is expected to be returned for analysis.

• 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: 18047812
• Report Number: 2124215-2023-60567
• Device Sequence Number: 7427784
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/08/2024

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: 01/02/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030781537
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown