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); Loss of consciousness (2418); Cardiac Perforation (2513); Pericardial Effusion (3271)
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Event Date 11/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, the transseptal puncture was performed with a competitor device and exchanged for the sheath.Prior to the first inflation with the sheath and balloon catheter in the heart, it was noted that the left heart border did not appear to be moving on the x ray.Imaging was preformed again and the heart border appeared to be moving.A fluorograph and echocardiogram were performed after the patient was given cardiopulmonary resuscitation (cpr) and a pericardial effusion was observed.The physician requested blood and the anesthesiologist.A sternotomy was performed and the patient was found to have a small hole on the ridge between the left atrial appendage and the left superior pulmonary vein.The procedure was aborted.Surgical intervention was performed successfully and the patient was stabilized.It was later noted by the physician that the trans-septal puncture was "clean" and there was a possibility that the tear was caused by the competitor guidewire but the physician was not sure.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that the patient was found to be unresponsive to name, and remained unresponsive.Therefore, an echo, drain, and subsequent surgical intervention were performed.No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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