Concomitant product: flexcath advance steerable sheath.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific patient or device information from the literature publication or to match the event with previously reported events.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.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The baseline gender/age of the patients represented in the article is male/(b)(6)old.The model listed in the report is a representative, 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.Referenced article: ¿incidence and factors associated with the occurrence of pulmonary vein narrowing after cryoballoon ablation.¿ (circ arrhythm electrophysiol.2017;10:e004588.Doi: 10.1161/circep.116.004588.) a good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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The literature publication reports the following patient complication while using a sheath catheter: there was one (1) patient who had an arteriovenous fistula requiring vascular surgery which took place on the seventh postoperative day.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/location of the sheath catheter is unknown.No further patient complications have been reported as a result of this event.
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