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

Model Number	VXAK0003
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/04/2025
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 cardiac perforation and pericardial effusion (pe) occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross connect for laac was selected for use.A mild effusion on the right side of the heart was noted during pre-imaging.The physician experienced difficulty accessing superior vena cava (svc) with a non-boston scientific (wholly) wire and subsequently the versacross connect rf wire.At multiple points the wire was exposed outside of the dilator, but without the full curl of the pigtail.Prior to transseptal, a larger effusion noted in most angles of the heart and change in heart motion was noted by the clinical specialist prompting further investigation by the physician and echocardiologist.It was agreed that the effusion had grown, but the implanting physician wanted to continue the procedure as long as the patient remained stable.Pressure dropped slightly, but was stable with medication.The watchman procedure was completed and the effusion remained stable throughout.After release of the device, the effusion was watched for ten to fifteen minutes and the patient was sent to the intensive care unit for further monitoring.In the physician opinion, it is believed the wire (either the wholly or versacross) could have created a small perforation in the right atrium prior to transseptal.The patient was doing well and no additional interventions were needed.Act was 339 after tsp.The patient has been discharged.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) patient codes (f10 and h6), in sections f - user facility / importer report information and h - device manufacturers only.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 cardiac perforation and pericardial effusion (pe) occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross connect for laac was selected for use.A mild effusion on the right side of the heart was noted during pre-imaging.The physician experienced difficulty accessing superior vena cava (svc) with a non-boston scientific (wholly) wire and subsequently the versacross connect rf wire.At multiple points the wire was exposed outside of the dilator, but without the full curl of the pigtail.Prior to transseptal, a larger effusion noted in most angles of the heart and change in heart motion was noted by the clinical specialist prompting further investigation by the physician and echocardiologist.It was agreed that the effusion had grown, but the implanting physician wanted to continue the procedure as long as the patient remained stable.Pressure dropped slightly, but was stable with medication.The watchman procedure was completed and the effusion remained stable throughout.After release of the device, the effusion was watched for ten to fifteen minutes and the patient was sent to the intensive care unit for further monitoring.In the physician opinion, it is believed the wire (either the wholly or versacross) could have created a small perforation in the right atrium prior to transseptal.The patient was doing well and no additional interventions were needed.Act was 339 after tsp.The patient has been discharged.The device is not expected to be returned for analysis (disposed).

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23638027
• Report Number: 2124215-2025-86050
• Device Sequence Number: 15767753
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: (01)00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/02/2026

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: 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female