MPRI ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number AFAPRO28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Nerve Damage (1979)
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Event Date 03/12/2024 |
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, there was an abrupt loss of phrenic capture while freezing the right superior pulmonary vein (rspv).The case was aborted while the patient was under general anesthesia.The patient was subjected to extended h ospitalization and it is unknown whether the phrenic nerve has recovered. no further 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 patient data files were returned and analyzed.One patient file received and recorded on the reported date of the event.The patient file showed that 12 applications were performed using an afapro28 balloon catheter with lot number 16538.The patient file did not show any system notice on the reported date of the event.The console output data (pressure, preset pressure, and flow) did not show any temperature artifact.The pressure was tracking preset pressure and flow readings were as expected.The failure file has not been received and the product was not returned.In conclusion, the reported clinical issue (phrenic nerve injury) occurred during the procedure and could not be assessed through data analysis.There is no indication of a relation of the adverse event to the performance or malfunction of the product.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was later reported that the procedure was completed with cryo and the phrenic nerve recovered the following day.
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