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 Codes	Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat a premature ventricular complex (pvc) in the coronary sinus (cs), an intellanav mifi open irrigated catheter was selected for use.A maestro 4000 system & metriq pump were also in use with a flow rate of 30 ml/min.When navigating into the coronary sinus, error message d05 excessive temperature was displayed on the generator and a leak was observed on the proximal end of the handle after the first ablation was started in the vein.Irrigation tube was observed detached.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter is expected to be returned for further analysis.
Event or Problem Description
It was reported that during an ablation procedure to treat a premature ventricular complex (pvc) in the coronary sinus (cs), an intellanav mifi open irrigated catheter was selected for use.A maestro 4000 system & metriq pump were also in use with a flow rate of 30 ml/min.When navigating into the coronary sinus, error message d05 excessive temperature was displayed on the generator and a leak was observed on the proximal end of the handle after the first ablation was started in the vein.Irrigation tube was observed detached.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter has been received by boston scientific corporation for laboratory analysis.
Additional Manufacturer Narrative
Intellanav mifi open-irrigated catheter was evaluated by boston scientific corporation.A media inspection was performed in the picture attached in the complaint and is possible to observe the irrigation extension tubing is totally detached/separated from the luer fitting at the adhesive joint.Visual inspection confirmed that the irrigation extension tubing was found totally detached/separated from the luer fitting at the adhesive joint.Finally, a functional test was done, and 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.Laboratory analysis was able to confirm the reported clinical observations.

• 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: 15809977
• Report Number: 2124215-2022-46852
• Device Sequence Number: 17524956
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/14/2022

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: 08/22/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030009298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male