It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced with resolve.The case was completed with cryo.Then, when performing test ablations, air bubbles were noted coming from the surface of the balloon of the second balloon catheter.No patient complications have been reported as a result of this event.
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Product event summary: the data files and balloon catheter afapro28 with lot, 28150 were returned and analyzed.The returned data files showed that eleven applications were performed.The files showed the occurrence of 50032, a system notice was received indicating that the safety system detected a compromised outer vacuum as well has high baseline flow and temperature fluctuations on the date of the event.Visual inspection of the catheter was intact with no apparent issues.Smart chip verification showed that the catheter had been used for nine applications on date of event.During inflation, the balloon was not inflated to its full inflated state due to outer balloon wrinkles.The catheter failed the performance test due to a continuous stream of bubbles escaping the outer balloon.The pressure test of the balloon catheter showed a double balloon breach.Both inner and outer balloons were breached at the same location.In conclusion, the reported issue of air ingress has been confirmed through testing.The catheter failed the returned product inspection due to the double balloon breach.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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