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.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is female/(b)(6).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: association of age with clinical features and ablation outcomes of paroxysmal supraventricular tachycardias.Heart.2021; 0:1¿7.Doi:10.1136/heartjnl-2021-319685.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports patients who underwent ablation and experienced pseudoaneurysm, permanent complete atrioventricular block with subsequent pacemaker implantation, and pro longed hospitalizations.The status/disposition of the catheters is unknown.No further patient complications have been reported as a result of this event.
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