It was reported that during a cryo ablation procedure, when the sheath was set up, it was not possible to aspirate it without air ingress.The sheath was replaced again without resolution.The sheath and balloon catheter were replaced and it was then not possible to aspirate at all.The balloon catheter and sheath were replaced again without resolution.After several sheath and balloon catheter combinations proper aspiration was not possible and the case was aborted.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 0010962376 was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomalies were identified during the external visual inspection.Functional testing and performance testing, with the sentinel blackbelt leak tester, were performed and all test results were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issues.In conclusion, the reported air ingress could not be confirmed through testing.The sheath did not fail the returned product inspection due to air ingress.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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