MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF283 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2022 |
Event Type
malfunction
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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, the guide wire lumen of the balloon catheter was kinked while ablating the right inferior pulmonary vein (ripv).The kink prevented the balloon catheter from being able to perform ablations.Thus, the balloon catheter 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 2af283 balloon catheter with lot 14966 was returned and analyzed.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 34 applications on the reported event date.The catheter was recognized and passed the electrical integrity verification 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 values were in range and the temperature curve had no oscillation or overshoot.For the steering test, the guide wire lumen was not straight when the balloon is fully extended.During inspection of the shaft segment, guide wire lumen kinks were observed at 1.052 <(><<)>(><(>&<)><(><<)>)> 1.4038 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.In conclusion, the reported guide wire lumen kink was confirmed.The balloon catheter failed the returned product analysis due to a guide wire 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.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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