PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
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Model Number 49341 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Flutter (1730)
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Event Date 11/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Event Description
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The patient had a concomitant surgical procedure of aortic valve replacement, ascending aorta replacement, maze, left atrial appendage (laa) ligation through sternotomy.During the same procedure on (b)(6) 2022 a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by an ft-10 generator were used.The left atrial appendage was stapled.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were achieved.21 days later, on (b)(6) 2022 the patient experienced atrial flutter.The patient came in during their 1 month visit and was found to be in atrial flutter.The adverse event was treated with medication, percutaneous intervention and external cardioversion.Three days later, the patient recovered.The adverse event was deemed by the sponsor as related to the concomitant procedure, study procedure and the cryoconsole but not rel ated to the cryoflex probe, cardioblate lp clamp or the ft-10 generator.The adverse event was deemed by the site as possibly related to the concomitant procedure, study procedure and the cryoflex probe, c ardioblate lp clamp but not related to the cryoconsole or the ft-10 generator.
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