(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
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Related manufacturer reference 3005188751-2015-00118, 3005334138-2015-00101.During a ventricular tachycardia ablation procedure, a pericardial effusion occurred.At the conclusion of the procedure, the patient became hypotensive and an echocardiogram revealed a pericardial effusion.The patient remained stable and no intervention was necessary.There were no performance issues with any sjm device.
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