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

Model Number	VXAK0007
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/13/2025
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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a perforation, pericardial effusion (pe) leading to cardiac tamponade occurred.The procedure was cancelled.During a watchman procedure, a versacross connect laac kit was selected for use.The physician attempted to go transeptal, advancing the wire multiple times.When watching on transesophageal echocardiogram (tee), there was visible tenting and radio frequency was administered.The wire did not cross into the left atrium so another attempt was made.The septum was slippery causing difficulty staying put on the septum.The procedure continued on trying to cannulate the appendage when an effusion was discovered.The effusion was measuring 2.5cm surrounding the heart.A pericardiocentesis began and when wire access was lost during that time the surgeon was called.Pericardial window was started and got 300 ml off before bag was attached.The patients chest was then cracked open on the table.The appendage was clipped.The patient remains stable and has throughout the entire procedure.The device is not expected to be returned for analysis (disposed).
Event or Problem Description
It was reported a perforation, pericardial effusion (pe) leading to cardiac tamponade occurred.The procedure was cancelled.During a watchman procedure, a versacross connect laac kit was selected for use.The physician attempted to go transeptal, advancing the wire multiple times.When watching on transesophageal echocardiogram (tee), there was visible tenting and radio frequency was administered.The wire did not cross into the left atrium so another attempt was made.The septum was slippery causing difficulty staying put on the septum.The procedure continued on trying to cannulate the appendage when an effusion was discovered.The effusion was measuring 2.5cm surrounding the heart.A pericardiocentesis began and when wire access was lost during that time the surgeon was called.Pericardial window was started and got 300 ml off before bag was attached.The patients chest was then cracked open on the table.The appendage was clipped.The patient remains stable and has throughout the entire procedure.The device is not expected to be returned for analysis (disposed).It was further confirmed that the patient did well after, went home and has already been seen in clinic.He is doing well and having no issues.There was tenting and the difficulty noted was with the patient's septum, which was very thick and stiff, making it difficult to maneuver the sheath once we crossed into the left atrium.The complication was noted while in the the la and when the tee physician noticed the effusion the procedure was stopped immediately and a pericardiocentesis was attempted.There were multiple drop downs and the pigtail wire had become misshapen.The physician believes this was part of the problem along with the patient's septum.The ct surgeon found that there was a small hole in the left atrium.The physician held pressure on the site with gauze until it was resolved.The patient had his appendage clipped by the ct surgeon while was in.Act was therapeutic during the procedure.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the update field describe event or problem (b5), in section b - adverse event/product pro.A separated report for versacross dilator is being submitted.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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.

• 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22127172
• Report Number: 2124215-2025-35911
• Device Sequence Number: 12638899
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/24/2025

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: VXAK0007
• Device Catalogue Number: VXAK0007
• Device Lot Number: 0035358841
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 10/03/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Race: White