MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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Model Number 2ACH15 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Tamponade (2226); Pericardial Effusion (3271); Embolism/Embolus (4438)
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Event Date 01/08/2022 |
Event Type
Injury
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Event Description
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A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports patients who underwent cryoballoon ablation and experienced periprocedural thromboembolic events, pericardial effusion with cardiac tamponade, persistent phrenic nerve palsy, and vascular groin complications.The status/disposition of the catheters and sheaths is unknown.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/63 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: news from the cold chamber: clinical experiences of polarx versus arctic front advance for single-shot pulmonary vein isolation.J.Cardiovasc.Dev.Dis.2022, 9, 16.Https://doi.Org/10.3390/jcdd9010016.If information is provided in the future, a supplemental report will be issued.
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