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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It was reported that during a pulsed field ablation procedure, isolation to all four pulmonary veins (pv) was confirmed without any issues.However, while confirming the right inferior pulmonary vein (ripv) isolation, the guidewire felt trapped in the loop catheter and it would not move forward.The loop catheter was removed from the patient without difficulties but visual inspection on the loop catheter observed coagulation trapped in the loop catheter's tip and a kink at one of the electrodes of the array.The case was completed with pulsed field ablation.The activated clotting time was noted to be lower but close to the expected value.No patient complications have been reported as a result of this event.
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