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	07/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
The intellanav open irrigated catheter was selected for use during the procedure to treat atrial flutter.It was reported that 'd05-excessive temperature' error appeared on the maestro generator after mapping and ablation in the left atrium and leakage was observed on the catheter's irrigation port around the tubing.It was noted there was no damage on the luer itself.Replacing the catheter resolved the issue.The procedure was completed succesfully without patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Device technical analysis: the device was received for analysis photographs provided made it possible to confirm that tubing set was damaged.During the product analysis was found that the device has the irrigation tube partially detached, consequently confirming the reported complaint.
Event or Problem Description
The intellanav open irrigated catheter was selected for use during the procedure to treat atrial flutter.It was reported that 'd05-excessive temperature' error appeared on the maestro generator after mapping and ablation in the left atrium and leakage was observed on the catheter's irrigation port around the tubing.It was noted there was no damage on the luer itself.Replacing the catheter resolved the issue.The procedure was completed succesfully without patient complications.The device is expected to be 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; la aurora - heredia MN 55112 -579; CS 55112-5798
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20019580
• Report Number: 2124215-2024-51629
• Device Sequence Number: 18284238
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Model Number: 87047
• Device Catalogue Number: 87047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown