(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 cardiac perforation was procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
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During an accessory pathway ablation procedure, a cardiac perforation occurred.While performing transseptal puncture, the needle was advanced across the septum and contrast was injected.When the needle was advanced further, contrast was injected again but noted in the pericardial space.An echocardiogram revealed a small pericardial effusion; however, the effusion did not enlarge and no intervention was required.The patient was transiently hypotensive, which was treated with administration of iv fluids, the procedure was successfully completed, and the patient was discharged in stable condition.There were no performance issues with any sjm device.
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