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/64 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:"femoral vascular complications after catheter ablation in the current era: the utility of computed tomography imaging" journal of cardiovascular electrophysiology.2020;31:1385¿1393.Doi: 10.1111/jce.14468.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 an ablation procedure using a cryoballoon ablation catheter system.After complaining of pain and swelling; two patients developed a hematoma; one patient experienced lymphorrhea; and one patient developed an atrioventricular (av) fistula.All four patients were treated with compression.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The status/location of the sheath is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
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