It was reported that a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention, and prolonged hospitalization.It was reported that during the procedure, a perforation was discovered.There was an immediate drop in blood pressure on the patient when the perforation occurred.The perforation was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.The patient had to be taken into surgery and when the event was called in was still in surgery.The patient¿s status was currently unknown.The physician believed the perforation occurred when the carto vizigo¿ 8.5f bi-directional guiding sheath - small dilator was being used to get the sheath across the septum after going transseptal and the dilator was inserted too far which perforated the left atrial appendage.Additional information was received on the event.Physician did not state his opinion on what caused the adverse event but did not mention it being a bwi product malfunction.Patient outcome is unknown after surviving open heart surgery.The patient required extended hospitalization due to open heart surgery and requirement of leaving the sternum open for two days prior to closure.Other relevant history includes: two prior afib ablations last one being in 2018.Ablation catheter not used for procedure.
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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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