MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSOMY

Model Number	VXAK0005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.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 pericardial effusion was noted that lead to surgical intervention where versacross connect laac access solution was used.The physician had difficulty visualizing the versacross connect laac access solution during the first and second attempt to cross the septum.Transseptal puncture was confirmed successful on the third attempt.After implanting the watchman device in the left atrial appendage, a final sweep was conducted, and a 2 cm sized effusion was noted in the right ventricle.Pericardiocentesis was performed.The patient remained in the icu and was discharged the next day.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report for the versacross rf wire which is part of the versacross connect laac access solution.A separate problem report has been submitted for versacross connect transseptal dilator which is part of the versacross connect laac access solution with the report number 3019751610-2023-00010.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 5959 trans-canada highway; montreal, quebec H4T 1-A1 ; CA H4T 1A1
• MDR Report Key: 16237548
• Report Number: 3019751610-2023-00011
• Device Sequence Number: 6405922
• Product Code: DXF
• UDI-Device Identifier: 00685447012580
• UDI-Public: (01)00685447012580(17)250408(10)VMFC140722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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): 01/24/2022

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: 04/08/2025
• Device Model Number: VXAK0005
• Device Lot Number: VMFC140722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2022
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown