This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: case report:managing profound circulatory collapse post-atrial fibrillation ablation: a methodical approach.European heart journal - case reports (2020) 4, 1¿5.Doi:10.1093/ehjcr/ytaa324.
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A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports a patient who experienced transient drops in blood pressure with no change in sinus rate during each pulmonary vein (pv) freeze, which responded well to intravenous (iv) fluids.Immediately post-ablation the patient developed profound recurrent hypotension which responded transientlyto iv fluids.Her physical examination was unremarkable, and her femoral access site appeared fine with no clinical evidence of hematoma.The patient then developed further recurrent profound hypotension responding initially to iv fluids but was associated with the reduced conscious level and metabolic acidosis.The patient was given iv adrenaline and received iv fluids including one unit of packed red cells, protamine iv, and prothrombin complex concentrate to treat a presumed acute bleeding event.An emergency computed tomography (ct) scan of the chest, abdomen, and pelvis with contrast was performed which excluded any bleeding source, esophageal injury, pulmonary embolism, and acute pv occlusion.The patient developed a further hypotensive episode which responded once again to iv fluids.Their electrocardiogram at that time revealed sinus bradycardia with intermittent pauses.An iv bolus of atropine was given and then commenced onto an isoprenaline infusion.After this, the patient stabilized and the isoprenaline infusion was stopped the following day.The status/disposition of the catheter is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.
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