Product event summary: the afapro28 balloon catheter with lot number 17206 was returned and analyzed.External visual inspection of the balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 22 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50032 "the safety system detected a compromised outer vacuum." pressure testing and inspection was performed on the sub-components of the balloon, handle, and shaft segments.During pressure testing of the balloon segment, an inner balloon breach (pinhole) was observed.Dissection did not show any signs of lifted thermocouple wires or leak detection wires that could have caused the breach.During inspection of the shaft segment, a guide wire lumen kink/twist was observed 1.07 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.Furthermore, a guide wire lumen kink and breach was observed 2.58 inches proximal to the catheter tip.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen breach and 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.
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