Product event summary: the afapro28 balloon catheter with lot number 07551 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 16 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005 "the safety system detected fluid in the catheter and stopped the injection." pressure testing and inspection was performed on the sub-components of the balloon, handle, and shaft segments.During inspection and pressure testing of the shaft segment, a guide wire lumen breach was observed at the catheter tip.During inspection of the handle segment, blood/ liquid was observed inside handle.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen breach on the attachment to the tip.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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It was reported that during a cryo ablation procedure, the balloon catheter was inserted into the sheath and air continued to be drawn when the reverse blood was drawn.The balloon catheter position was shifted which did not resolve the issue.The sheath was replaced which resolved the issue.The procedure proceeded.The esophageal temperature decreased while ablating the left inferior pulmonary vein (lipv) and a double stop was performed.Immediately following the double stop, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The procedure continued without replacing the balloon catheter.The case was completed with cryo.No patient complications have been reported as a result of this event.
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