MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0003
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a pericardial effusion occurred and the procedure was cancelled.It was reported that versacross connect laac access solution was selected for watchman left atrial appendage closure procedure.During the procedure, when attempt was made for transseptal using versacross rf wire, it failed to cross, and no bubbles were noted in left atrium (la).So, a second attempt was made to cross, and bubbles were seen, however, the versacross rf wire did not cross.A third attempt was made and same issue noted.The physician tried different positioning on septum by putting more bend on versacross dilator.Transesophageal echocardiogram (tee) was checked, and a pericardial effusion was noted around right ventricle.Patient blood pressure was dropped when pe had occurred.A pericardiocentesis was performed due to hemodynamic compromise and 360 cc dark red blood was removed.The patient was admitted to hospital beyond standard of care and expected to fully recover.The device is not expected to be returned for analysis (disposed).It was confirmed that heparin was given just prior to transseptal puncture.No versacross device malfunctions were reported.It was noted a difficult visual windows due to heart rotated.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21349842
• Report Number: 2124215-2025-07160
• Device Sequence Number: 7740972
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0003
• Device Catalogue Number: VXAK0003
• 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: 01/21/2025
• Initial Report FDA Received Date: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Race: White