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 Atrial Flutter (1730); Chest Pain (1776)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device was not received at boston scientific for analysis.Based on the information provided, "the patient was complaining of chest pain post-procedure." the instructions for use states: adverse events which may be associated with catheterization and ablation include: 'chest discomfort.' since the reported adverse events are known and documented in the labeling, including both short or long term known complications or adverse reactions, the most probable cause of known inherent risk of the device is selected for the complaint.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The reported event was not confirmed because the device was not 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.

Event Description

(b)(6) study - subject id: (b)(6).An index ablation procedure involving an intellanav stablepoint open-irrigated catheter was completed on (b)(6) 2022.It was reported that on (b)(6) 2022 the patient complained of chest pain post-procedure.The patient underwent a transthoracic echocardiogram (tte).The patient's oral medication was changed or adjusted to naprosyn 500 mg twice a day (bid) for 3 days, and colchine 0.6mg for a month.It was also reported that the patient experienced an atrial flutter (af) episode that went into atypical atrial flutter at the moment the patient was to be discharged.The af did not convert with flecainide and pronestyl.The patient was discharged even though he was in arrhythmia, and an electrical cardioversion was planned.

• 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 DE COSTA RICA S.R.L; 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: 14107386
• MDR Text Key: 289258276
• Report Number: 2134265-2022-04367
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2022

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 Model Number: M004IDERFS96200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 86 KG