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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Search Alerts/Recalls
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