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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 04/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: afapro28 balloon catheter.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.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, a system notice was received indicating that the safety system detected a compromised outer vacuum.The electrical umbilical cable, which had been re-sterilized, was replaced without resolution.The balloon catheter was then replaced which resolved the issue.The left superior pulmonary vein (lspv) was treated.During treatment of the left inferior pulmonary vein (lipv), the electric potential disappeared and cardiac arrest of unknown cause occurred. the treatment was discontinued, the procedure was aborted, and the patient was rescued.Return of spontaneous circulation (rosc) occurred and the patient left the room. no further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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