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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number M004IDERFS96200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Pericarditis (4448)
Event Date 12/15/2021
Event Type  Injury  
Event Description
(b)(6) clinical study.Index ablation procedure with a intellanav stablepoint open-irrigated catheter was performed on (b)(6) 2021.It was reported that the patient experienced chest pain on (b)(6) 2021.The patient was admitted for hospitalization.Ultrasound/echocardiogram/tee/tte was performed.No additional information was provided.
 
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
(b)(6) clinical study.Index ablation procedure with a intellanav stablepoint open-irrigated catheter was performed on (b)(6) 2021.It was reported that the patient experienced chest pain on (b)(6) 2021.The patient was admitted for hospitalization.Ultrasound/echocardiogram/tee/tte was performed.Additional information received indicated that the patient had increased chest pain, shortness of breathe, and fatigue despite receiving colchicine post procedure.The patient was discharged to home on (b)(6) 2021.The official diagnosis was pericarditis.A follow-up appointment with the cardiologist was scheduled for (b)(6) 2021.
 
Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.Additional information was added to b5 event description and f10 patient and impact codes.
 
Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.Additional information was added to b5 event description.
 
Event Description
Newton af clinical study: index ablation procedure with a intellanav stablepoint open-irrigated catheter was performed on (b)(6) 2021.It was reported that the patient experienced chest pain on (b)(6) 2021.The patient was admitted for hospitalization.Ultrasound/echocardiogram/tee/tte was performed.Additional information received indicated that the patient had increased chest pain, shortness of breathe, and fatigue despite receiving colchicine post procedure.The patient was discharged to home on (b)(6) 2021.The official diagnosis was pericarditis.A follow-up appointment with the cardiologist was scheduled for (b)(6) 2021.Furthermore, the event was noted as resolved on (b)(6) 2021.
 
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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 Key13206056
MDR Text Key283502306
Report Number2134265-2022-00101
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/12/2023
Device Model NumberM004IDERFS96200
Device Lot Number0026800698
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age63 YR
Patient SexFemale
Patient Weight67 KG
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