(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
|
During a ventricular tachycardia ablation procedure, a pericardial effusion occurred.Ventricular tachycardia was induced prior to performing transseptal puncture and proceeding with the procedure.A flexability catheter was used to create geometry of the left ventricle.After approximately one hour of mapping, the catheter was displayed in an unusual space on ensite.An ice catheter was then advanced into the right ventricle which revealed an effusion.A pericardiocentesis and surgical repair of the left ventricular apex were required to resolve the effusion and stabilize the patient.There were no performance issues with any sjm device.
|