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

Model Number M004IDERFS96200

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Inflammation (1932)

Event Date 01/08/2022

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)(6) study.It was reported that intellanav stablepoint ablation catheter was used in a ablation procedure on (b)(6) 2022.Two days following the index procedure on (b)(6) 2022, the patient experienced inflammation of the pericardium with symptoms including chest tightness & shortness of breath.The patients was given colchicine twice daily to 0.6 mg instead of just once a day.

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)(6) study.It was reported that intellanav stablepoint ablation catheter was used in a ablation procedure on (b)(6) 2022.Two days following the index procedure on (b)(6) 2022, the patient experienced inflammation of the pericardium with symptoms including chest tightness & shortness of breath.The patients was given colchicine twice daily to 0.6 mg instead of just once a day.

Event Description

Newton af clinical study.It was reported that intellanav stablepoint ablation catheter was used in a ablation procedure on (b)(6) 2022.Two days following the index procedure on (b)(6) 2022, the patient experienced inflammation of the pericardium with symptoms including chest tightness & shortness of breath.The patients was given colchicine twice daily to 0.6 mg instead of just once a day.

Manufacturer Narrative

The device has not been received for analysis; 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.Medical device info has been corrected.

Manufacturer Narrative

The device has not been received for analysis; 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

Pc053 newton af clinical study subject id: (b)(6).It was reported that intellanav stablepoint ablation catheter was used in a ablation procedure on (b)(6) 2022.Two days following the index procedure on (b)(6) 2022, the patient experienced inflammation of the pericardium with symptoms including chest tightness & shortness of breath.The patients was given colchicine twice daily to 0.6 mg instead of just once a day.It was further reported that the event was considered resolved on (b)(6) 2023.

• 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: 13509525
• MDR Text Key: 285674782
• Report Number: 2134265-2022-01464
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: M004IDERFS96200
• Device Lot Number: 0027388804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 41 KG