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Model Number 10FCC20 |
Device Problems
Gas/Air Leak (2946); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
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 pulsed field ablation procedure, the side port of the sheath had a kink in it.The sidearm of the sheath was against the patient, and while aspiration was being performed, microbubbles were observed in the sidearm.Despite the issues, case was completed with pulsed field ablation. no patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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