It was reported that during a cryo ablation procedure, after exchanging from a competitor sheath to the sheath for the cryo procedure, air was observed in the left atrium and aorta near the brachiocephalic artery.When the dilator was removed and aspiration was attempted, air was pulled into the syringe.The case was aborted.A brain scan was performed and no anomalies were observed.The patient was reported to be stable post-procedure.No further patient complications have been reported as a result of this event.
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Product event summary: the sheath 4fc12 with lot number 0010680960 was returned and analyzed.Visual inspection showed that the sheath was intact and had no apparent issues.The deflection mechanism functioned as per specification.The reported air ingress issue was not reproduced during testing.A leak test for the sheath was done on the sentinel blackbelt tester, the pressure decay was within an acceptable limit.The shaft and the valve were leak tight with no apparent issues.Several aspiration/flushing tests were performed, and they did not show any air passing through the tube or expelled from the sheath distal tip.In conclusion, the clinical issues (air embolism and st elevation) could not be confirmed through testing.The reported air ingress could not be confirmed through testing.The balloon catheter passed the returned product inspection as per specifications.There is no indication of relation of adverse events to the performance of the product.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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