(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported cardiac perforation, hematoma, embolus, and thrombosis could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
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Related manufacturer reference: 9680001-2017-00052, 2030404-2017-00028, 3005334138-2017-00092.The following was published in the journal of arrhythmia 33 (2017) 167-171, page 168, 169 and 170.¿the patients were divided into 2 groups, rmn and a man group.A total of 443 patients were included in the study.The rmn group consisted of 214 patients and man group consisted of 229 patients.After pre-procedural transesophageal echocardiograms to exclude left atrial clot, vascular access was obtained via the femoral veins, and multipolar catheters were placed in the coronary sinus and selectively in the right ventricle.Transseptal punctures were performed fluoroscopically and depending on the physician¿s preference, with intracardiac ultrasound guidance.Sw or sl1 sheaths (st jude medical inc., (b)(4)) were advanced into the left atrium.Heparin was administered upon left atrial access and an activated clotting time of 250-400s was the target for anticoagulation throughout the procedure.For the man group, ablation was done by standard technique utilizing flexibility, tacticath and inquiry optima plus catheters.Both groups had one patient each where the development of pericardia effusions necessitated mid-procedural abandonment, for which they were also considered failed procedures.Among patients in the man group, 2 patients developed significant pericardia effusions during ablation and required emergency pericardiocentesis.The third patient who had tamponade suffered right atrial perforation during difficult trans-septal puncture and was not catheter related.Two patients in the man group suffered significant hematomas prolonging inpatient stay because of difficult groin access, 1 patient had an intra-procedural air embolism and another patient had a deep vein thrombosis post procedure.The other documented complications included post procedure stroke, access site bleeding with partial thrombosis, and a pulmonary venous infarction from an occluded lingular branch of the pulmonary vein in a patient that presented with hemoptysis.".
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