MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number M004ERFSDS96200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pericarditis (4448)

Event Date 03/01/2022

Event Type  Injury  

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 Description

(b)(4) clinical study, subject id: (b)(6).Index ablation procedure was performed on (b)(6) 2022, with an intellanav stablepoint open-irrigated catheter.It was reported that the patient experienced pericarditis one day post procedure.The event is ongoing.No additional information has been reported.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Newton af clinical study, subject id: (b)(6).Index ablation procedure was performed on march 01 2022, with an intellanav stablepoint open-irrigated catheter.It was reported that the patient experienced pericarditis one day post procedure.The event is ongoing.Additional information received indicated that the patient presented with light chest pain post ablation and the suspected cause was the index ablation procedure.Naproxen and colchicine were administered.

Event Description

Newton af clinical study, subject id: (b)(6).Index ablation procedure was performed on march 01 2022, with an intellanav stablepoint open-irrigated catheter.It was reported that the patient presented with light chest pain and pericarditis post ablation post procedure.The suspected cause was the index ablation procedure.Naproxen and colchicine were administered.The event is ongoing.Additional information received indicated the date of event was march 01 2022.

Manufacturer Narrative

Additional information was added to b3, b5.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Newton af clinical study (b)(4).Index ablation procedure was performed on (b)(6) 2022, with an intellanav stablepoint open-irrigated catheter.It was reported that the patient experienced light chest pain pericarditis post procedure.The suspected cause was the ablation procedure.Naproxen and colchicine was adjusted.It was further reported that the event was resolved on (b)(6) 2022.A repeat ablation procedure was also performed on (b)(6) 2022.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLANAV STABLEPOINT OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 13771437
• MDR Text Key: 287246728
• Report Number: 2134265-2022-02943
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: M004ERFSDS96200
• Device Lot Number: 0026788899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/19/2022; 05/13/2022; 02/17/2023
• Supplement Dates FDA Received: 04/14/2022; 06/01/2022; 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 93 KG