Concomitant medical products: achieve mapping catheter.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/63 years old.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.Referenced article: ¿is less more? impact of different ablation protocols on periprocedural complications in second-generation cryoballoon based pulmonary vein isolation.¿ europace (2017) 00, 1¿9.Doi:10.1093/europace/eux219.If information is provided in the future, a supplemental report will be issued.
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The literature publication reports the following patient complications while using a sheath catheter: there were eight (8) patients who had groin complications; two of which required surgical/interventional repair.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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