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.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: ¿complications in catheter ablation of atrial fibrillation in 3,000 consecutive procedures balloon versus radiofrequency current ablation.¿ j am coll cardiol ep 2017; 3:154¿61.Doi.Org/10.1016/j.Jacep.2016.07.002.
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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 26 patients with ¿vascular access¿ complications, with no treatment/resolution indicated.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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