It was reported that during a cryo ablation procedure, air bubbles were observed entering the sheath when initiating the continuous flow pump.Also, compatibility issues occurred between the sheath and the dilator.The sheath was 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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Product event summary: the 4fc12 sheath with lot number 0010706099 was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection.The handle, shaft and sideport were intact with no apparent issue.Visual inspection of the dilator was performed.The inspection identified the dilator tip, shaft and luer was intact with no apparent issue.The dilator was inserted into the sheath and was snap-locked into the sheath properly.Visual inspection and magnifying with a high-resolution microscope revealed dilator luer was intact without any issue.The performance test with sentinel blackbelt leak tester was performed.The pressure test with 30 psig showed the pressure decay in the device was out of range.The flushing test with six psig showed the pressure decay in the device psig was out of range psig.The aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was out of range.T he performance test failed.Dissection and pressure testing of the returned device revealed a leakage at the bond between the shaft and valve assembly.In conclusion the reported air ingress was confirmed through testing and a bond leak was observed at shaft to hemostasis valve assembly fitting.The sheath failed the return product inspection due to the shaft attachment to the valve being torn.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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