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 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to boston scientific for analysis.Per visual inspection it was observed a foreign material around the irrigation holes.After functional test 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 problems.Flow test showed that 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 continuity test was performed and no problems were detected.Per noise test the device was able to complete an rf ablation test at cooling flow set to 17 ml/min at power at 20w for 10s with average readings for electrogram noise during rf < 142 vrms.Noise values were found out of specifications.

Event Description

Reportable based on device analysis completed on 9june2022.It was reported that during a procedure to treat pulmonary vein isolation with cavotricuspid isthmus an intellanav mifi open-irrigated catheter showed noisy channels on mifi 1, contributing to noise on 1-2 and 3-1, especially when on radio frequency (rf).Normal mifi pacing did not improve the issue.Noise was observed on both recording and mapping system.Generator used was the maestro 4000 and the pump was metriq pump.Impedance values had normal variance between 100's and 120's.No error message was observed.Noise was present from the start of the case and it was high frequency at baseline and short bursts during rf of higher amplitude and frequency noise.Issue was solved by exchanging the catheter and no patient complications were reported.However, device analysis found a foreign material around the irrigation holes and the device present noise in the electrical test.

• 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: 14860897
• MDR Text Key: 302711964
• Report Number: 2134265-2022-07525
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0027880744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male