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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It was reported that after performing the transseptal puncture with another manufacturer¿s needle and sheath/dilator system, contrast was injected and the system was advanced into the left atrium.The other manufacturer¿s sheath/dilator system was replaced with a medtronic sheath.The cryo balloon catheter system was inserted into the sheath.The mapping catheter was in the left appendage.Prior to inflating the balloon catheter, the patient became hypotensive.A transthoracic echocardiogram was used and a pericardial effusion was observed.The procedure was aborted and a pericardiocentesis was carried out.The patient blood pressure stabilized and was then sent to the intensive care unit (icu) for recovery.No further patient complications have been reported as a result of this event.
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