The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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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It was reported that a female patient (approx.100lbs) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a vein perforation requiring surgical intervention and prolonged hospitalization.It was reported that during an afib case, a vein perforation was found as the patient blood pressure dropped and a venogram done on the patient confirmed it.The caller stated that a vascular surgeon was called in and a venous stent was put in place.The patient was moved to the icu after the intervention and is currently on a ventilator.There was no ablation that was conducted; however, the ablation catheter was in the body.The patient required extended hospitalization as the patient remained intubated for several days and renal function was monitored.The patient¿s condition has improved.The physician¿s opinion on the cause of this adverse event is that it is procedure related.
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