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

Model Number	VXAK0103
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/27/2025
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a hematoma, perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.There was no effusion noted prior to procedure.Using watchman sheath and versacross system, the physician tented the septum and a mid-superior and mid-posterior puncture was selected based on the left atrial appendage (laa) anatomy.The tenting was visualized mid and posterior on corresponding bicaval and short axis transesophageal echocardiogram (tee) views.The physician exposed the versacross radio frequency (rf) wire 1-3mm from the tip of the dilator in the usual fashion.Tenting visualized and rf delivery was attempted.At this point, the tent was posterior in the short axis and slide anterior as rf was turned on.Bubbles were not visualized in the left atrium and access to left atrium was not gained.The rf wire was visualized on flouro retract/curl back on itself on the right side of the heart.The wire was immediately retracted into the dilator and removed off the septum.The tee imager noted a anteriorly pericardial effusion that was new.Thickening noted around the aorta, md called it a hematoma.The patient's systolic blood pressure decreased to 75mmhg which was previously over 130mmhg.Immediately a pericardiocentesis was performed.Around 200 cc red bloody fluid was removed from the pericardium.Patient's blood pressure stabilized and was transferred to the cardiac intensive care in stable condition.The patient was discharged three days after the procedure.The device is not expected to be returned for analysis (disposed).The patient was not under warfarin nor antiplatelet drugs at the time.
Event or Problem Description
It was reported that a hematoma, perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.There was no effusion noted prior to procedure.Using watchman sheath and versacross system, the physician tented the septum and a mid-superior and mid-posterior puncture was selected based on the left atrial appendage (laa) anatomy.The tenting was visualized mid and posterior on corresponding bicaval and short axis transesophageal echocardiogram (tee) views.The physician exposed the versacross radio frequency (rf) wire 1-3mm from the tip of the dilator in the usual fashion.Tenting visualized and rf delivery was attempted.At this point, the tent was posterior in the short axis and slide anterior as rf was turned on.Bubbles were not visualized in the left atrium and access to left atrium was not gained.The rf wire was visualized on flouro retract/curl back on itself on the right side of the heart.The wire was immediately retracted into the dilator and removed off the septum.The tee imager noted a anteriorly pericardial effusion that was new.Thickening noted around the aorta, md called it a hematoma.The patient's systolic blood pressure decreased to 75mmhg which was previously over 130mmhg.Immediately a pericardiocentesis was performed.Around 200 cc red bloody fluid was removed from the pericardium.Patient's blood pressure stabilized and was transferred to the cardiac intensive care in stable condition.The patient was discharged three days after the procedure.The device is not expected to be returned for analysis (disposed).The patient was not under warfarin nor antiplatelet drugs at the time.
Additional Manufacturer Narrative
The device did not return for analysis.However, the reported allegation of pericardial effusion is confirmed based on the media provided.All other allegations cannot be confirmed with the information available.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e - initial reporter.

• 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): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22520765
• Report Number: 2124215-2025-47509
• Device Sequence Number: 12920040
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)280116(10)35910114
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 10/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0103
• Device Catalogue Number: VXAK0103
• Device Lot Number: 0035910114
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• Date Device Manufactured: 01/16/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Race: White