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Model Number 4FC12 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
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Event Date 10/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product event summary: the data files were returned and analyzed.The data files showed system notice #(b)(4) ¿there is a problem with the injection process¿ in application 1 with catheter 2af283 with lot number 19930.The files showed at least 1 application was performed with this catheter on the date of the event.The second patient file 3 hours later showed at least 4 applications were performed with balloon catheter 2af283 lot number 98653 without any issue on the date of the event.Clinical issues (cardiac tamponade, hypotension) occurred during the case.In conclusion, the sheath was not returned for investigation.There is no indication of relation of adverse event to the performance of the cryo device.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, the patient had cardiac tamponade, diagnosed by fluoroscopy and ultrasound echocardiogram, as well as low blood pressure.The blood was drained and the patient underwent protamine treatment.The case was aborted with the patient under general anesthesia.The patient was hospitalized.No further patient complications have been reported as a result of this event.
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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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Additional information indicated the patient was hospitalized for an extended period of time, and was now discharged; the patient recovered.
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Search Alerts/Recalls
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