This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age characteristics is male/(b)(6) years old.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.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:multi-catheter cryotherapy compared with radiofrequency ablation in long-standing persistent atrial fibrillation: a randomized clinical trial" journal of interventional cardiac electrophysiology.Europace (2021) 23, 370¿379.Doi:10.1093/europace/euaa289.If information is provided in the future, a supplemental report will be issued.
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The literature publication reported the following patient complications during a cryoablation procedure: two cases of profound hypotension occurred after administration of adenosine.In both cases, this progressed to cardiac arrest but recovered completely after r resuscitation including the administration of adrenaline and fluid.One patient experienced a pseudoaneurysm of the right femoral artery that required prothrombin injection, one had a pericardial effusion that required drainage three hours after the procedure.The status of the catheters is unknown.Follow up is being conducted for additional information on the catheters.No further patient complications have been reported as a result of this event.
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