It was reported that during a watchman left atrial appendage closure (laac) procedure, a pericardial effusion and cardiac tamponade occurred post procedure.After obtaining right femoral vein access, an nrg rf transseptal kit (nrg needle and troflex sheath) was inserted.There were multiple attempts of dropping onto the fossa and transseptal puncture was performed however while crossing with stiff wire, the right superior pulmonary vein (rspv) access was lost.The physician then performed another transseptal puncture using versacross connect kit (pigtail rf wire and single curve sheath/dilator) with no complications.The sheath was advanced into the left atrial appendage (laa) and the dilator was removed.Act result was 230 and an additional 2000 units of heparin given.Watchman device was inserted with one recapture performed, met the pass criteria and was released.All devices were removed from the body.There was no effusion noted at this point.After one hour while the patient being in recovery, patient became hypotensive and diaphoretic.It was discovered that the patient had a pericardial effusion with cardiac tamponade.The patient was brought back to the lab where the physician performed a pericardiocentesis.675ml of blood was removed from the patient before the patient became stable.The patient was admitted to hospital beyond standard of care and expected to be fully recovered.The device is not expected to be returned for analysis.
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