MPRI ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF284 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure, air bubbles were present during aspiration after the insertion of the balloon catheter into the sheath.The balloon catheter was removed and reprepared without resolution.Subsequently, the balloon catheter and sheath were 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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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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Manufacturer Narrative
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Product event summary: the 2af284 balloon catheter with lot number 10817 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 reviewed.Data indicated the catheter was never used (no application performed).The catheter was recognized and passed the electrical integrity verifications 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 were in range and temperature curve had no oscillation or overshoot.During device compatibility inspection (balloon catheter insertion into the sheath), the outer balloon distal bond diameter was measured out of specification.The outer balloon distal bond measured 0.162 inches (specification is <(><<)>0.157 inches).The user may experience insertion, flushing and purging air issues from the sheath due to this issue.In conclusion, the reported air ingress issue could not be confirmed.The balloon catheter failed the return product inspection due to the outer balloon distal joint outer diameter being out of specification.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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