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/62 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: "second-generation cryoballoon-based pulmonary vein isolation: lessons from a five-year follow-up" international journal of cardiology.2020.Doi.Org/10.1016/j.Ijcard.2020.03.062.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: four (4) patients experienced phrenic nerve palsy (pnp), all recovered within 12 months, four (4) patients developed severe groin hematomas, including one (1) patient that developed an arterial-venous fistula that was treated by thrombin injection.One (1) patient demonstrated an asymptomatic pericardial effusion, and another patient developed postprocedural pericardial tamponade requiring pericardiocentesis.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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