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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144); Respiratory Insufficiency (4462)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ablation procedure to treat atrial fibrillation using an intellanav mifi open-irrigated catheter, and prior to discharge, the patient experienced pulmonary insufficiency with low oxygen saturation, nausea, vomiting, and severe headache.The patient was administered oxygen (o2) for the desaturation, and a chest x-ray and laboratory blood tests were performed for diagnostics.The patient was hospitalized for observation over the course of two days, after which the patient recovered from the complications and was discharged.The device is not expected to be returned for analysis.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that after an ablation procedure to treat atrial fibrillation using an intellanav mifi open-irrigated catheter, and prior to discharge, the patient experienced pulmonary insufficiency with low oxygen saturation, nausea, vomiting, and severe headache.The patient was administered oxygen (o2) for the desaturation, and a chest x-ray and laboratory blood tests were performed for diagnostics.The patient was hospitalized for observation over the course of two days, after which the patient recovered from the complications and was discharged.The device is not expected to be returned for analysis.It was further reported that the symptoms of nausea and vomiting did not occur.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 18388610
• Report Number: 2124215-2023-72245
• Device Sequence Number: 4020472
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0031269754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 92 KG