Product event summary: the 4fc12 sheath with lot number 0011574230 was returned and analyzed.Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator.Visual inspection identified a shaft kink/twist at approximately 6 inches and another shaft kink/twist at approximately 22 inches from the tip.Functional testing was performed.The insertion of the dilator into the sheath was performed.The dilator luer could not be locked into the sheath.Further inspection under microscope identified a dilator luer damage, which may have caused the dilator to have difficulties locking with the sheath.In conclusion, the sheath failed the returned product inspection due to the shaft kink.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.If information is provided in the future, a supplemental report will be issued.
|