Product event summary: the 4fc12 sheath with lot number 0010582927 was returned and analyzed.Visual inspection of the sheath showed the shaft was wrinkled proximal from the tip end.The sheath was received assembled to a afapro28 balloon catheter with lot number 13934.X-ray imaging showed the marker band was deformed and compressed against the pull wire ring.The balloon was retracted without any issues.The inner diameter measurement of the tip of the sheath of 0.158 was within specification.Dissection of the sheath confirmed the marker band was deformed and compressed against the pull wire ring.Dissection showed the tip was damaged and teflon delamination at the tip.Wrinkles most likely occurred due to a shaft compression as a result of opposite longitudinal forces between the sheath and balloon catheter handles during catheter retraction.In conclusion, the reported sheath twist was not confirmed through testing.The sheath passed the returned product inspection as per specification.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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