It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The balloon catheter, electrical umbilical cable and coaxial umbilical cable were replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
|
Product event summary: data files and the afapro28 with lot number 20002 were returned and analyzed.The patient files showed at least ten applications were performed with the reported balloon catheter without any issue on the date of the event.Patient files also showed at least 11 more applications were performed with non-returned balloon catheter afapro28 with lot number 20015 without any issue on the date of the event.The failure file confirmed system notice #50005 ¿leak detection¿ between using the above catheter.Visual inspection of the balloon catheter was performed.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 10 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice #50005.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.In conclusion, the 50005 system notice was confirmed through testing and the balloon catheter failed the returned product inspection due to a breach on the guide wire lumen on the attachment to the tip and a kink/twist on the guide wire lumen.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.
|