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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
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Event Date 02/27/2023 |
Event Type
Death
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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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It was reported that during a cryo ablation procedure, there was an unknown difficulty and the physician decided to touch-up the left superior pulmonary vein (lspv) with radiofrequency.The sheath and balloon catheter were withdrawn into the right atrium (ra), leaving the mapping catheter in the left atrium.After mapping the left atrium, the mapping catheter was replaced with another manufacturer¿s product.After energizing the bottom anterior wall of the lspv for touch-up three times, the patient became hypotensive, a cardiac tamponade was observed on imaging, and drainage was performed.The patient¿s consciousness was confirmed.Subsequently, bleeding was observed again in the patient¿s puncture site and in the heart.Medicine was used to treat the patient with no effect.The patient expired.
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Search Alerts/Recalls
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