There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
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A case of pericardial effusion was reported in a procedure where the versacross rf wire and versacross transseptal sheath were used among other devices, including the watchman delivery sheath and amplatzer pfo occluder.Successful transseptal puncture was completed using the versacross rf wire and the versacross transseptal sheath.The watchman delivery sheath was advanced into the left atrium following removal of the versacross transseptal sheath.The versacross rf wire was removed and the amplatzer pfo occluder was implanted.A pericardial effusion sweep was performed, and an effusion was noted.The patient was stabilized.There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, 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 has been submitted for the versacross rf wire under mfr report number: 3019751610-2022-00016.
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