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It was reported that a (b)(6) female patient underwent a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac tamponade requiring monitoring and procedure discontinuation.It was reported that during septal puncture, imaging in the right atrium revealed cardiac tamponade.This occurred during septal puncture.Drainage was attempted but was not performed because pericardial fluid did not accumulate enough to puncture the drainage needle.Although the condition was observed in an angina room, blood pressure, etc.Were stable, and marked pericardial effusion was not confirmed by echocardiography.The procedure was discontinued.The patient was then transferred to the intensive care unit (icu).Additional information was received on the event.The physician commented that relationship with the product was not mentioned.Regarding the cause of this event, the physician stated, "due to the somewhat complex running of blood vessels from the sheath puncture site to the heart, it was difficult to hang the septal puncture needle in the atrium.The relation with the product was not mentioned by the physician in charge.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is the patient condition and the procedure.No intervention was provided.The patient outcome of the adverse event is improved.
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Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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