MAUDE Adverse Event Report: VERSACROSS TRANSSEPTAL SHEATH; CATHETER, SEPTOSTOMY

Model Number	VXS85-35-63-45-D0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as a baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.Dhr review was completed for the lot in question, and it was confirmed that all devices met relevant requirements prior to release.
Event or Problem Description
A case of pericardial effusion was reported in a mitraclip procedure where the versacross transseptal sheath and the versacross rf wire were used among other devices including the supracore wire (abbott).A 3mm cut was located between the right atrium and the superior vena cava.Pericardiocentesis was performed to drain the effusion and the procedure was aborted.There is no evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as a baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A separate problem report has been submitted for the versacross rf wire with the report number 9710452-2021-0024.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Common Device Name: CATHETER, SEPTOSTOMY
• MDR Report Key: 11679553
• Report Number: 9710452-2021-00023
• Device Sequence Number: 11818633
• Product Code: DYB
• UDI-Device Identifier: 00685447003380
• UDI-Public: (01)00685447003380(17)230812(10)VXFB031220
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: VXS85-35-63-45-D0
• Device Lot Number: VXFB031220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention