It was reported that during a cryo ablation procedure, while ablating the right upper pulmonary vein.The balloon catheter was slightly deformed when inflated.When occluding the right inferior pulmonary vein (ripv), the balloon catheter was completed deformed and could not complete occlusion.The balloon catheter was replaced to resolve the issue. no patient complications have been reported as a result of this event.
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Product event summary: the 2af283 balloon catheter with lot 15922 was returned and analyzed.Visual inspection was performed a kink/twist was observed on the guide wire lumen and a kinked injection tube was observed at the balloon segment area.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.The catheter was recognized and passed the electrical integrity verifications and performance test.The catheter completed the inflation, ablation, and thawing phases with no console system notices generated.No performance issues were identified.All pressure and flow were in range and the temperature curve had no oscillation or overshoot.During inspection of the balloon segment, a kink was observed on the injection tube.The injection tube was kinked at the balloon area.During inspection of the shaft segment, a guide wire lumen kink/twist was observed 1.34 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.In conclusion, the balloon catheter failed the returned product inspection due to the injection tube kink and the guidewire lumen 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.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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