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

Model Number 87047

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received at boston scientific for analysis.Visual inspection using an electron microscope revealed a foreign material with a yellow-brown color inside the tip of the device.It was not possible to identify the nature of the organic residue.In the flow, the device presented a partial obstruction in some of the irrigation holes.The unit passed functional, leak, and continuity tests.The device did not pass the electrical test since there was evidence of noise.Analysis of the returned product revealed that the unit showed no evidence or defects that could have contributed to the tracking/accuracy issue event, consequently, not confirming this reported failure.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.

Event Description

Reportable based on analysis completed on 15 jun 2022.During the ischemic ventricular tachycardia ablation, an intellanav mifi oi catheter was selected for use.It was reported that there was noise and static on all surfaces and intracardiac electrograms.This issue occurred while manipulating.The catheter had intermittent visibility on the rhythmia.The mifi oi catheter was replaced, and the case was successfully completed.No patient complications were reported.Product analysis revealed there was a foreign material in the distal tip and in the flow.The device presented a partial obstruction in some of the irrigation holes.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: 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: 14989546
• MDR Text Key: 304018812
• Report Number: 2134265-2022-07848
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0028819477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1