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 Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was not returned; therefore, product analysis could not be performed.There are two pictures attached in the complaint and confirm the lot# and the upn of the device reported, also one of the pictures is a error message of the metriq pump.The reported complaint cannot be confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.No issues were found that could have been related to the reported issue during manufacturing documentation review.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.
Event or Problem Description
The intellanav mifi open-irrigated catheter was selected for use during a premature ventricular contractions ablation procedure.It was reported that the error 'purge stopped pressure limited' error would reoccur on the pump while trying to purge the catheter.They were unable to successfully flush the catheter, therefore, it was replaced with a new one from the different model.The procedure was then completed successfully without patient complications.The device was not 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: 16690133
• Report Number: 2124215-2023-14085
• Device Sequence Number: 12611697
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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: 08/23/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030011238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown