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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The intellanav mifi catheter open-irrigated catheter was selected for use during an ablation procedure to treat atrial fibrillation.It was reported that the catheter's fluid port broke, and fluid leaked at the proximal end of the handle which triggered a high temperature alert to occur on the maestro 4000 system.The catheter was replaced with one from the same model, however, the new catheter broke as well.The flow rate was at 30 milliliter per minute.They replaced the catheter once more.The procedure was able to be completed successfully.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The intellanav mifi open-irrigated ablation catheter was returned to boston scientific for analysis.Visual inspection revealed the irrigation extension tubing was totally detached and separated from the luer fitting at the adhesive joint.Therefore, the reported complaint tubing set of fluid leak and device displays error message is confirmed.
Event or Problem Description
The intellanav mifi catheter open-irrigated catheter was selected for use during an ablation procedure to treat atrial fibrillation.It was reported that the catheter's fluid port broke, and fluid leaked at the proximal end of the handle which triggered a high temperature alert to occur on the maestro 4000 system.The catheter was replaced with one from the same model, however, the new catheter broke as well.The flow rate was at 30 milliliter per minute.They replaced the catheter once more.The procedure was able to be completed successfully.No patient complications were reported.The device was 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: 16404692
• Report Number: 2124215-2023-05631
• Device Sequence Number: 5632445
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/28/2023

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: 03/17/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0029066010
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White