MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 990063-020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Hypoxia (1918)
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Event Date 03/25/2024 |
Event Type
Injury
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Manufacturer Narrative
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D10:concomitant prod:continued: afapro28 balloon catheter; 4fc12 sheath.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 a cryo ablation procedure while searching for the right superior pulmonary vein (rspv), the patient's carbon dioxide (co2) pressure decreased, and blood was observed in the intubation canula.Additionally, the patient presented with anoxia.The blood was aspirated from the lung.The procedure was aborted, and the patient was under general anesthesia.The patient was sent to the intensive care unit (icu).The intubation tube was removed the next day.No further patient complications have been reported as a result of this event.
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