Achieve mapping catheter.Medtronic cryocath 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 characteristic is male/(b)(6), for the patients referenced in the article.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: ¿the role of novel oral anticoagulants in patients undergoing cryoballoon ablation for atrial fibrillation.¿ hellenic journal of cardiology (2016) 57, 331e337.Http://dx.Doi.Org/10.1016/j.Hjc.2016.11.003.
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The literature publication reports the following patient complication while using a sheath catheter: multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.There were 15 patients who experienced bleeding during the ablation procedure.There was medication administered, but with unknown resolution.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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