MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 990063-020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pericardial Effusion (3271)
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Event Date 03/11/2024 |
Event Type
Injury
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Event Description
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It was reported that during a cryo ablation procedure, the mapping catheter was advanced into the right superior pulmonary vein (rspv), but under fluoroscopy, it seemed the mapping catheter was not in the rspv.An echocardiography revealed a pericardial effusion.Pericardial drainage was performed and the procedure was aborted when the effusion was no longer observed.No further 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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