It was reported that during a cryo ablation procedure, the patient lost consciousness and a pericardial tamponade was discovered.Bleeding could not be stopped, so the case was aborted.The patient was sent to surgery and the patient became stable.The patient's hospitalization was extended two days.No further patient complications have been reported as a result of this event.
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Product event summary: patient data files showed at least nine applications were performed with balloon catheter, 2af283 lot number 56676, without any issue on the date of the event.Visual inspection of mapping catheter, 990063-020 lot number 220110420, showed the shaft was broken around the middle distal from the ecg connector (most likely post procedure); no ecg signal wires were broken inside the shaft.The tip and loop section were intact with no issue.In conclusion, clinical issue (cardiac tamponade, bleeding and loss of consciousness) occurred during the procedure.The case was aborted.There is no indication of relation of adverse event to the performance and malfunction of the product.The mapping catheter failed the inspection due to a broken shaft.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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