The versacross rf wire and the versacross transseptal sheath were used for transseptal puncture during a cryo ablation procedure.Upon successful transseptal puncture, the physician exchanged the versacross transseptal sheath with the cryo sheath and dilator.The physician attempted to dilate the septum further using the cryo dilator but the cryo sheath was unable to cross.The cryo sheath and dilator were removed and the expansure large access transseptal dilator was used in an attempt to further dilate the septum.The cryo sheath and dilator were attempted again but was again unsuccessful.During preparation for a second transseptal puncture, the devices were removed from the left atrium and a drop of pressure was observed.A pericardial effusion was observed on fluoroscopy and a pericardial effusion tap protocol was initiated.As baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A separate mdr problem report has been submitted for the versacross rf wire and expansure large access transseptal dilator under mfr report number: 3019751610-2022-00015 and 3019751610-2022-00013.
|