MPRI ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF284 |
Device Problems
Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Flutter (1730)
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Event Date 05/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that during a cryo ablation procedure, after freezing both the left superior and inferior veins, the patient went into atrial flutter.Pacing maneuvers were unsuccessful.The patient was cardioverted.After the cardioversion, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The continue button was pressed which resolved the issue.The patient went back into atrial flutter again and had to be cardioverted again.The same system notice occurred again.The coaxial umbilical cable was replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the 2af284 balloon catheter with lot 07412 was returned and analyzed.Visual inspection was performed, and a breach was observed on the guide wire lumen on the attachment to the tip.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 19 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005 (indicating that the safety system detected fluid in the catheter and stopped the injection.) during pressure testing and dissection of the balloon segment, no anomalies were identified.Both balloons and bonding were intact.During inspection and pressure testing of the shaft segment, a guide wire lumen breach was observed at the catheter tip.In conclusion, the reported clinical issues (atrial flutter) were not confirmed through product analysis.The balloon catheter failed the returned product inspection due to a breach 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.
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