It was reported that during a cryo ablation procedure, when introducing the balloon catheter into the sheath, air bubbles were observed in the sheath port.The balloon catheter was removed and the air bubbles were attempted to be aspirated out of the port.However, the air bubbles continued to appear.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 was returned and analyzed.Visual inspection of the shaft area was performed.The i nspection identified a shaft kink/twist at approximately 2.5 inches from the tip.Performance tests with sentinel blackbelt leak tester was conducted.The sheath failed the test as the pressure decay in the device was 1.892 psig (should be less than 0.945 psig).Dissection and pressure testing of the returned device revealed a leakage at the hemostasis valve; the valve disk was suspected to be torn.In conclusion, the reported air ingress was confirmed through testing.The sheath failed the returned product inspection due to a shaft kink and twist and hemostatic valve leak.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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