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	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure to treat atrial arrhythmia, the intellanav mifi open-irrigated catheter was selected for use.It was reported that they had two catheters with issues.The first catheter had a standard curve and was used for the majority of the procedure until it could no longer be steered.The device had to be replaced with a new catheter that had a large curve to continue the procedure.However, after using the second catheter for a short duration a d07 temperature too high error occurred on the maestro.The tip was not being properly cooled during radio frequency delivery.The catheter was inspected, damage and leakage were observed at the luer hub where the metriq tubing set was connected to the catheter.It was noted that the flow rates were standard for the power settings.The physician attempted to deliver a couple of additional 20watt lesions without having the temperature cut off.They were able to complete the procedure without performing any troubleshooting.No patient complication was reported.The device is expected to be returned for analysis.
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.
Additional Manufacturer Narrative
The intellanav mifi catheter was returned to boston scientific for laboratory analysis.Visual inspection found the irrigation extension tubing partially detached/separated from the luer fitting at the adhesive joint.Therefore, the reported complaint is confirmed.
Event or Problem Description
During an ablation procedure to treat atrial arrhythmia, the intellanav mifi open-irrigated catheter was selected for use.It was reported that they had two catheters with issues.The first catheter had a standard curve and was used for the majority of the procedure until it could no longer be steered.The device had to be replaced with a new catheter that had a large curve to continue the procedure.However, after using the second catheter for a short duration a d07 temperature too high error occurred on the maestro.The tip was not being properly cooled during radio frequency delivery.The catheter was inspected, damage and leakage were observed at the luer hub where the metriq tubing set was connected to the catheter.It was noted that the flow rates were standard for the power settings.The physician attempted to deliver a couple of additional 20watt lesions without having the temperature cut off.They were able to complete the procedure without performing any troubleshooting.No patient complication was reported.The device has been 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: 15771488
• Report Number: 2124215-2022-45510
• Device Sequence Number: 6490051
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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: 05/18/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0027331218
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown