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 Problems
Material Integrity Problem (2978); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a cryo ablation procedure, while ablating the right lower pulmonary vein (pv), a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The freeze stopped and the balloon catheter could not be reinflated and a system notice was received indicating that the safety system detected a compromised outer vacuum.The coaxial umbilical cable was replaced without resolve.The balloon catheter was replaced to resolve the issue.Upon removal it was found that the inner and outer balloon layers were separated. 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 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 reported that during a cryo ablation procedure, while ablating the right lower pulmonary vein (pv), a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The freeze stopped and the balloon catheter could not be reinflated and a system notice was received indicating that the safety system detected a compromised outer vacuum.The coaxial umbilical cable was replaced without resolve.The balloon catheter was replaced to resolve the issue.Upon removal it was found that the inner and outer balloon layers were separated. 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 number 25266 and the data files were returned and analyzed.The patient file showed 10 applications were performed using the faulty balloon catheter, and 3 applications were performed using the replacement balloon catheter.The patient file also showed system notice #50032 (the safety system has detected a compromised outer vacuum) during inflation/transition at application #6 to 10 with the first catheter.The patient file for the second catheter showed system notice #50001 (the vacuum is disabled due to a problem with the coaxial umbilical cable) during ablation at application #11 and 13; and system notice 50030 (the safety system has detected a high level of refrigerant flow and stopped the injection) during transition at application #12.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 12 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice #50032.During pressure testing of the balloon segment, an inner balloon breach was observed.Dissection of the balloon segment identified an inner balloon material fracture.In conclusion, the reported 'double balloon damage" was confirmed during analysis, and the balloon catheter failed the returned product inspection due to an inner balloon breach.The breach was a material/crack on the surface of the inner balloon.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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