Model Number M004IDERFS96200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Inflammation (1932)
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Event Date 01/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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(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.
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Manufacturer Narrative
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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.
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Event Description
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(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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Search Alerts/Recalls
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