Product event summary: the 4fc12 sheath was returned and analyzed.Visual inspection was performed, and no defects were identified.External visual inspection was performed, and no anomaly was identified; the handle, shaft and sideport were intact with no apparent issue.Functional testing was performed, and no anomaly was discovered.The steering mechanism and deflection test were performed.The shaft was bending as initially intended and was bending in the plane.There was no difficulty, no friction, or any noise in the steering mechanism.The performance test was performed with a leak tester.The pressure test with 30 psig showed the pressure decay in the device was 0.058 psig (should be less than 0.3 psig).The flushing test with 6 psig showed the pressure decay in the device was 0.002 psig (should be less than 0.2 psig).The aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was 0.003 psig (should be less than 0.2 psig).All the performance tests were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issue.In conclusion, the reported air ingress issue was not confirmed through product analysis.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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It was reported that during a cryo ablation procedure, the introducer was pulled off the balloon too far.The blue push button on the handle had to be used to get the balloon back into the introducer.After the sheath and balloon catheter were prepped and inserted into the body, the pump that was attached to the sheath gave a 'pressure' alarm.The sheath was switched to a different pump, the balloon catheter was removed, re-prepped, and reinserted.After the balloon catheter was reinserted, the new pump and the sheath displayed microbubbles.The tubing was replaced and the saline bag was heparinized without resolution.The sheath was replaced without resolution.The balloon catheter was then replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
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