Product event summary: the data files containing an image and the 4fc12 sheath with lot number 0011921477 were returned and analyzed.The data files contained an image which showed a filament of the dilator luer polyethylene protruding out.The sheath was visually inspected.No anomaly was identified during the external visual inspection.The handle, shaft and sideport were intact with no apparent issues.Visual inspection of the dilator was carried out and identified the dilator luer was delaminated.Functional testing was performed and the dilator was inserted into the sheath.Unable to lock the dilator luer into the sheath.Further inspection under microscope identified dilator luer damage.In conclusion, the dilator filament protruding issue was confirmed through analysis and the sheath failed the returned product inspection due to delamination at the dilator polyethelene and dilator luer damage.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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