MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number AFAPRO28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Low Oxygen Saturation (2477)
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Event Date 03/18/2024 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported that during the cryo ablation procedure, there was difficulty maintaining the patient's blood oxygen saturation levels due to conscious sedation and inability to maintain the patient's airway.Before creating a lesion to the right superior pulmonary vein (rspv), phrenic nerve capture was documented, however, at the end of the lesion, phrenic nerve capture was lost.The diaphragm was observed to be moving under fluoroscopy, but the capture could not be "felt." the procedure continued with additional lesions to the left superior pulmonary vein (lspv); however, the patient's blood oxygen saturation levels continued to drop, requiring the patient to be intubated.The case was aborted.It was surmised that sedation and the patient's pre-existing sleep apnea contributed to the adverse events.The patient was admitted to the intensive care unit (icu) for overnight hospitalization. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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