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.
|
|
Search Alerts/Recalls
|