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, after isolating four pulmonary veins (pv), the pulsed field ablation catheter was removed and another manufacturer's mapping catheter was reinserted.After the posterior wall ablation was "successfully carried" out, an attempt was made to remove the pulsed field ablation catheter but the slider tool would only advance half way and it was stuck.The physician pulled it back into the sheath.When pulsed field ablation catheter was removed there was visible wire exposed from the catheter. the case was completed with pulsed field ablation. no patient complications have been reported as a result of this event.
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