MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 990063-020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiopulmonary Arrest (1765); Vascular Dissection (3160); Pericardial Effusion (3271)
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Event Date 12/14/2017 |
Event Type
Injury
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Event Description
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It was reported that during a cryo ablation procedure, the patient had a pericardial effusion, which was confirmed via intracardiac echocardiography (ice).The case was aborted, and the patient was under general anesthesia.Subsequently, the patient required cardiopulmonary resuscitation (cpr), and open chest thoracotomy.The patient was then transported to the operating room (or) for a subsequent procedure or surgery.The patient's hospitalization was extended.The patient is recovering, and the extent of permanent injuries were unable to be determined.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the data files were returned and analyzed.The data files did not show any system notice for the date of the event.The mapping catheter was not returned and there was no indication of a product malfunction.Some known clinical issues (cardiac perforation, pericardial effusion, tamponade and pulmonary vein tear) were encountered during the procedure.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received indicated that during the open chest thoracotomy, a pulmonary vein (pv) tear was found and repaired.Additionally, the patient has since been discharged home.
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Search Alerts/Recalls
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