It was reported that a patient, (b)(6), male, underwent a pulmonary vein isolation (pvi) procedure with a thermocool smarttouch bi-directional navigation catheter and a carto 3 mapping system and suffered a cardiac tamponade, which required a pericardiocentesis.Ten days after the procedure, the patient was diagnosed with a late tamponade.The physician performed a pericardiocentesis on the patient.The patient fully recovered and is clinically asymptomatic.Additional information was received on the event.A transseptal puncture was performed with an unknown needle.Anticoagulation was provided to the patient and maintained at 250-300s during the procedure.After the pvi, the patient suffered from thoracic pain, subfebrility, dyspnea, coughing, fever, sweating, 8kg weight gain with swollen feet, abdomen and orthopnea.The patient did require hospitalization due to the pericardiocentesis.It is unknown when the event occurred but it is thought to have probably occurred during the ablation phase.Settings during the event include: temperature control mode / irrigation flow setting 17-30ml/min / 8f preface sheath was used.The physician's opinion regarding the cause of this adverse event is that this is procedure related as a result of excessive ablation due to the use of visitag.Since the use of visitags, physicians tend to ablate until a certain fti value is reached.This might lead to overshooting.Therefore in taking a conservative approach, this event is also be reported under both the ablation catheter and the carto 3 system.The bwi awareness date for this complaint is 9/23/2015, the date in which a bwi employee was first made aware of this adverse event.
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(b)(4) it was reported that a patient, 63 year old, male, underwent a pulmonary vein isolation (pvi) procedure with a thermocool® smarttouch® bi-directional navigation catheter and a carto 3 mapping system and suffered a cardiac tamponade, which required a pericardiocentesis.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related as a result of excessive ablation due to the use of visitag.Since the use of visitags, physicians tend to ablate until a certain fti value is reached.This might lead to overshooting.Therefore in taking a conservative approach, this event was also reported under both the ablation catheter and the carto 3 system.Bwi representative informed they are not requesting the system to be checked.The system is ready for use.The history of customer complaints associated with carto 3 system # 10386 was reviewed.There were not any additional complaints that may be related to the reported issue.Device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to address this issue.
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