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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat an atrial tachycardia, an intellanav mifi open-irrigated catheter was selected for use.Metriq pump & maestro 4000 generator were used.Flow rate was 17 ml/min.After seven minutes of ablation, the irrigation port on the catheter fractured and started leaking fluid.A small crack in the tubing near the luer lock connection was noticed and fluid was leaking from the luer lock connection to the tubing on the catheter side.Excessive temperature alarm was seen on the generator.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.
Additional Manufacturer Narrative
Intellanav mifi open-irrigated catheter was evaluated by boston scientific corporation.A visual inspection was performed and the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint.Also, a media inspection was done on the picture attached in the complaint, and it is possible to observe the irrigation extension tubing partially detached/separated from the luer fitting at the adhesive joint.Laboratory analysis was able to confirm the reported clinical observations.
Event or Problem Description
It was reported that during an ablation procedure to treat an atrial tachycardia, an intellanav mifi open-irrigated catheter was selected for use.Metriq pump & maestro 4000 generator were used.Flow rate was 17 ml/min.After seven minutes of ablation, the irrigation port on the catheter fractured and started leaking fluid.A small crack in the tubing near the luer lock connection was noticed and fluid was leaking from the luer lock connection to the tubing on the catheter side.Excessive temperature alarm was seen on the generator.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter was returned to boston scientific corporation for laboratory 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: 16184226
• Report Number: 2124215-2022-56213
• Device Sequence Number: 2429175
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: 08714729938385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/07/2023

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: 11/06/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030496977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown