Product event summary: the 4fc12 sheath with lot 0010314844 and returned electronic photo were analyzed.Visual examination of the provided photo shows a deformation of the sheath.It is not possible to assess the leaking issue or air ingress through the photo of hemostasis valve, as it needs to be tested to check any potential leak through the silicone valve.The opening of the valve shown in the photo could be related to the retraction of the catheter from sheath.Visual inspection of the sheath showed the shaft was intact with no apparent issues.Performance testing with sentinel blackbelt leak tester revealed the pressure decay was in an acceptable range.The shaft and valve were leak tight with no apparent issues.The flush and air aspiration/ingress issue was not reproduced.Several flushes and aspirations were performed without issues while a test balloon catheter was inserted.There was no blockage along the shaft and the shaft and side port was leak tight.St elevation may occur in the absence of a product malfunction.Product anomalies in the catheter and sheath may also lead to air ingress or st elevation, though no anomaly was seen with the sheath.The cause of the adverse event could not be determined for this event.In conclusion, a clinical issue (st elevation) occurred during the case.The reported air ingress and hemostatic valve issue were not confirmed through testing.There is no indication of a relation of the adverse event to the performance and malfunction of the product.The sheath passed the returned product inspection as per specification.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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