Product event summary: the afapro28 balloon catheter with lot number 20003 was returned and analyzed.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was downloaded and reviewed.The data indicated the catheter was used for 16 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50032 (a system notice was received indicating that the safety system detected a compromised outer vacuum).During the inflation, a kinked guide wire lumen was observed inside of the balloon.Pressure testing and inspection of the subcomponents of the catheter, handle, and shaft segments were performed.During inspection of the shaft segment, a guide wire lumen kink/twist was observed 1.25 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.During inspection and pressure testing of the handle segment, air escaping through the laser hole was observed inside of the y-block fitting.The adhesive seal at the proximal end of the catheter shaft was breached.In conclusion, the balloon catheter failed the returned product analysis due to a guidewire lumen kink and a leak observed at the outer vacuum lumen on the proximal end inside of the y-block.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.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.
|
It was reported that during a cryo ablation procedure, an unknown system notice occurred.Additionally, occlusion issues were noted.The case was switched to radiofrequency (rf) ablation. the case was completed with radiofrequency. no patient complications have been reported as a result of this event.
|