It was reported that a thrombosis occurred.During a watchman procedure to treat gastrointestinal bleeding (gib), a versacross connect kit was selected for use.The transseptal puncture was performed and the watchman sheath was advanced.Approximately two minutes following the completion of the transseptal crossing, a long, string-like thrombus was noted attached to the watchman sheath via transesophageal echocardiography (tee).Following transseptal crossing, a full dose of heparin was given to the patient.The physician attempted to aspirate the thrombus, and the thrombus was pulled out of the left atrium.Additional heparin was given and repeated activated clotting times were drawn until the patient had an activated clotting time over 300 seconds.The watchman device was then implanted and the procedure completed successfully.The patient was discharged home the same day post procedure.The device is not expected to be returned for analysis.The physician felt that versacross connect system in conjunction with the watchman fxd double curve sheath may have a played a role in the thrombus forming.
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