Model Number PSCC100 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
Event Type
malfunction
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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, the pulsed field ablation catheter guide wire was pulled back in attempt to redirect it into a right middle pulmonary vein.While being readvanced into the atrium the catheter loop became inverted on itself. the pulsed field ablation catheter was removed from the body and attempts were made to manually restore the catheter to its original configuration without resolve.The pulsed field ablation catheter was replaced to resolve the issue. the case was completed with pulsed field ablation. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Correction updated b5.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 pulsed field ablation procedure.
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Search Alerts/Recalls
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