MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0005
Medical Device Problem Codes	Positioning Failure (1158); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Hematoma (1884); Pericardial Effusion (3271)
Date of Event	11/20/2025
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.A separated report for the versacross rf wire is being submitted.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a pericardial effusion (pe) and hematoma occurred.During a watchman implant procedure, a versacross connect laac was selected for use.There was no effusion noted prior to procedure.During pre-procedure transesophageal echocardiogram (tee), the interatrial septum (ias) was noted to be diffusely thick with only a small 0.5-1.0cm thin portion located anteriorly, and the team anticipated that transseptal puncture (tsp) would be challenging.The physician attempted tsp using the watchman trusteer access system (was) with the versacross connect.Multiple attempts were made over 30-40 minutes to obtain a perpendicular tent on the thin portion of the ias.One anterior/mid tsp attempt was performed yet bubbles and the versacross wire remained on the right atrial side, confirming unsuccessful crossing.Once a perpendicular tent position was again visualized (mid in the bicaval view and anterior in short axis), a single radiofrequency (rf) pulse was delivered.No wire or bubbles were visualized in the left atrium (la), although the physician believed the wire crossing on fluoroscopy.The physician advanced the was and versacross dilator.Tee then revealed that the was had crossed the thick ias tissue, extending parallel to and wrapping around the aortic valve (av) but without penetrating through to the valve.The entire system was withdrawn, and patient hemodynamics remained stable.A standard 8.5f versacross system was then opened and used to successfully obtain safe tsp.The watchman closure device was subsequently deployed and implanted without further difficulty.Tee then identified a hematoma at the site where the was and versacross system entered the thick septal tissue, along with a small, stable pe located anteriorly near the av.No intervention was required, and the procedure was concluded.The patient was admitted to the intensive care unit (icu) for overnight observation and remained stable.The patient is expected to fully recover.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event or product problem.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.A separated report for the versacross dilator is being submitted.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 pericardial effusion (pe) and hematoma occurred.During a watchman implant procedure, a versacross connect laac was selected for use.There was no effusion noted prior to procedure.During pre-procedure transesophageal echocardiogram (tee), the interatrial septum (ias) was noted to be diffusely thick with only a small 0.5-1.0cm thin portion located anteriorly, and the team anticipated that transseptal puncture (tsp) would be challenging.The physician attempted tsp using the watchman trusteer access system (was) with the versacross connect.Multiple attempts were made over 30-40 minutes to obtain a perpendicular tent on the thin portion of the ias.One anterior/mid tsp attempt was performed yet bubbles and the versacross wire remained on the right atrial side, confirming unsuccessful crossing.Once a perpendicular tent position was again visualized (mid in the bicaval view and anterior in short axis), a single radiofrequency (rf) pulse was delivered.No wire or bubbles were visualized in the left atrium (la), although the physician believed the wire crossing on fluoroscopy.The physician advanced the was and versacross dilator.Tee then revealed that the was had crossed the thick ias tissue, extending parallel to and wrapping around the aortic valve (av) but without penetrating through to the valve.The entire system was withdrawn, and patient hemodynamics remained stable.A standard 8.5f versacross system was then opened and used to successfully obtain safe tsp.The watchman closure device was subsequently deployed and implanted without further difficulty.Tee then identified a hematoma at the site where the was and versacross system entered the thick septal tissue, along with a small, stable pe located anteriorly near the av.No intervention was required, and the procedure was concluded.The patient was admitted to the intensive care unit (icu) for overnight observation and remained stable.The patient is expected to fully recover.The device is not expected to be returned for analysis (disposed).It was further reported that no perforation was noted and the patient remained stable.Act was therapeutic.The patient has been discharged.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 23778844
• Report Number: 2124215-2025-90365
• Device Sequence Number: 10117465
• Product Code: DRE
• UDI-Device Identifier: 00685447010517
• UDI-Public: (01)00685447010517
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 01/13/2026

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: VXAK0005
• Device Catalogue Number: VXAK0005
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White