MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number	VXS85-35-63-45-D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as a baylis medical device was 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 and the device fulfilled all requirements prior to release.
Event or Problem Description
A case of pericardial effusion was reported in a procedure where the versacross transseptal sheath and versacross rf wire were used among other devices, including the cryo sheath catheter.Intra-cardiac echocardiograph confirmed there was an effusion, after baylis medical products had been removed from the patient.Pericardiocentesis was performed but the effusion persisted so the doctor transferred the patient to surgery.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.Caused or contributed to the reported incident.However, as a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.A separate mdr has been submitted for the versacross rf wire under mfr report number: 9710452-2021-00045.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• MDR Report Key: 12664500
• Report Number: 9710452-2021-00046
• Device Sequence Number: 4161810
• Product Code: DYB
• UDI-Device Identifier: 00685447003588
• UDI-Public: (01)00685447003588(17)240127(10)VXFE310521
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/20/2021

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: 01/27/2024
• Device Model Number: VXS85-35-63-45-D1
• Device Lot Number: VXFE310521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/20/2021
• 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: Required Intervention