ST. JUDE MEDICAL, INC. FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER
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Model Number A701125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 12/03/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is a known inherent risk of any electrode placement.
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Event Description
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During a ventricular tachycardia ablation procedure, a pericardial effusion occurred.A flexibility ablation catheter was used to perform ablation in the left ventricle and the patient became hypotensive.An echocardiogram revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any sjm device.
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Search Alerts/Recalls
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