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

Model Number	VXAK0003
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/27/2025
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.
Event or Problem Description
A pericardial effusion (pe) occurred.It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the pericardial space was inadvertently accessed during attempted transseptal crossing.The versacross rf wire was pulled back and readvanced multiple times into the right atrium and a pe was noted by transesophageal echocardiogram, posterior to the left ventricle.The effusion appeared stable after monitoring and patient's vital signs were unchanged.Decision was made to implant the watchman device and place a pericardial drain at the end of the procedure.Transseptal puncture was reattempted successfully and watchman device placed without incident, meeting pass criteria.Once watchman access sheath was removed, heparin was reversed with protamine and the physician proceeded with pericardiocentesis/drain placement.A total of 120ml of sanguinous/blood colored fluid drained by aspiration.The effusion was resolved, and the drain was left in place to monitor for 24 hours before removing.The patient was hospitalized beyond standard of care and it is expected to fully recover.Product is not expected to return for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drug at the time.In the physician's opinion, pericardial space was inadvertently accessed during attempted transseptal crossing; felt the location of the attempted transseptal was possibly too anterior.The effusion measured 5mm at the time that it was initially noted and measured 7mm at the time pericardiocentesis was started, following successful watchman deployment.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updates on the fields describe event or problem (b5), in section b - adverse event/product prob; patient codes and device codes (f10 and h6), in sections f - for use by uf/importer and h - device manufacturers only.A separate problem report will be filed for the versacross dilator.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
A pericardial effusion (pe) occurred.It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the pericardial space was inadvertently accessed during attempted transseptal crossing.The versacross rf wire was pulled back and readvanced multiple times into the right atrium and a pe was noted by transesophageal echocardiogram, posterior to the left ventricle.The effusion appeared stable after monitoring and patient's vital signs were unchanged.A decision was made to implant the watchman device and place a pericardial drain at the end of the procedure.Transseptal puncture was reattempted successfully and watchman device placed without incident, meeting pass criteria.Once watchman access sheath was removed, heparin was reversed with protamine and the physician proceeded with pericardiocentesis/drain placement.A total of 120ml of sanguinous/blood colored fluid drained by aspiration.The effusion was resolved, and the drain was left in place to monitor for 24 hours before removing.The patient was hospitalized beyond standard of care and it is expected to fully recover.Product is not expected to return for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drug at the time.In the physician's opinion, pericardial space was inadvertently accessed during attempted transseptal crossing; felt the location of the attempted transseptal was possibly too anterior.The effusion measured 5mm at the time that it was initially noted and measured 7mm at the time pericardiocentesis was started, following successful watchman deployment.It has been further mentioned that a perforation was also noted, the rf wire was noted to be in the pericardial space through echo.The physician believes that the trajectory of the rf wire may have changed due to patient anatomy.They also mentioned that it was difficult to confirm position on the septum when preparing for transseptal access, possibly due to an enlarged right atrium.Rf was applied a total of 4 times with the same wire, no excessive force was used during attempts.When the rf wire was removed from the patient, the pigtail portion was elongated, thought to be due to excess compression when in the pericardial space.Patient has been discharged home.

• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21405688
• Report Number: 2124215-2025-09598
• Device Sequence Number: 18201673
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/11/2025

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: 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: 01/27/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White