ST. JUDE MEDICAL INQUIRY STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number IBI-81107 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemothorax (1896); Cardiac Perforation (2513)
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Event Date 05/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference: 2182269-2020-00050, 3008452825-2020-00256, 3008452825-2020-00257, 2182269-2020-00051.During ventricular tachycardia mapping in the left ventricle, a pericardial effusion occurred.After approximately an hour of mapping, using transseptal approach, the patient became hypotensive.An ultrasound confirmed a pericardial effusion for which a pericardiocentesis was administered.An additional ultrasound confirmed a hemothorax on the left side of the thorax, which was treated with a thorax drain.The cause and location of the pericardial effusion remains unknown, however it was noted the transseptal puncture was difficult.The patient was stable with minimal use of catecholamines and transferred to the icu.There were no performance issues with any abbott device.
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Manufacturer Narrative
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Additional information: d10, g4, g7, h2, h3, h6, h10.One inquiry¿ steerable diagnostic catheter was received for investigation.The catheter shaft deflected when actuating the steering mechanism and deflected in the correct shape according to specifications and electrodes 1-10 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
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