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

Model Number	VXAK0007
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a cardiac tamponade and pericardial effusion occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.Pre-procedural transesophageal echocardiography (tee) identified a small pericardial effusion present at baseline.The versacross connect system was introduced through the watchman sheath to perform the transseptal puncture (tsp).The device was advanced into the superior vena cava (svc) and maneuvered down to the interatrial septum under tee guidance.The septum was noted to be highly aneurysmal with a small right atrium to maneuver in, making visualization of tenting difficult.The physician manipulated the was sheath to locate tenting without exposing the pigtail wire.Following the tsp, the imager monitored for changes in the pericardial effusion while the pigtail catheter was inserted.An increase in the size of the effusion was observed (bilateral).Subsequently, the patient developed atrial fibrillation along with hypotension.Cardioversion was performed, and the effusion was monitored.An laa angiogram was conducted, confirming no contrast leakage from the appendage into the left atrium (la).The physician elected to abort the procedure due to the increased effusion.All devices were withdrawn from the la, and anticoagulation was reversed.1000 units given until septum was crossed then remainder full dose was given.Effusion was noted 1-3 minutes after remaining dose was given followed by mild cardiac tamponade noted.The patient was stable, though the effusion continued to expand slowly.The patient was transferred to the operating room (or), where pericardiocentesis was performed, and approximately 800cc of blood was drained from the pericardial space.The patient blood was not given back, 800cc was drained but it was already clotting, additional units were given.The patient remained in the hospital for recovery and was reported to be doing well with no further complications.The device is not expected to be returned for analysis (disposed).Elequis administered a week ago for hematuria.
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.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 yet.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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.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 a cardiac tamponade and pericardial effusion occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.Pre-procedural transesophageal echocardiography (tee) identified a small pericardial effusion present at baseline.The versacross connect system was introduced through the watchman sheath to perform the transseptal puncture (tsp).The device was advanced into the superior vena cava (svc) and maneuvered down to the interatrial septum under tee guidance.The septum was noted to be highly aneurysmal with a small right atrium to maneuver in, making visualization of tenting difficult.The physician manipulated the was sheath to locate tenting without exposing the pigtail wire.Following the tsp, the imager monitored for changes in the pericardial effusion while the pigtail catheter was inserted.An increase in the size of the effusion was observed (bilateral).Subsequently, the patient developed atrial fibrillation along with hypotension.Cardioversion was performed, and the effusion was monitored.An laa angiogram was conducted, confirming no contrast leakage from the appendage into the left atrium (la).The physician elected to abort the procedure due to the increased effusion.All devices were withdrawn from the la, and anticoagulation was reversed.1000units given until septum was crossed then remainder full dose was given.Effusion was noted 1-3 minutes after remaining dose was given followed by mild cardiac tamponade noted.The patient was stable, though the effusion continued to expand slowly.The patient was transferred to the operating room (or), where pericardiocentesis was performed, and approximately 800cc of blood was drained from the pericardial space.The patient blood was not given back, 800cc was drained but it was already clotting, additional units were given.The patient remained in the hospital for recovery and was reported to be doing well with no further complications.The device is not expected to be returned for analysis (disposed).Elequis administered a week ago for hematuria.It was further reported that the perforation was not confirmed.A pericardiocentesis and drain were performed but no window.1000units given until septum was crossed then remainder full dose was given.Effusion was noted 1-3 minutes after remaining dose was given followed by mild cardiac tamponade noted.The patient was discharged home on: (b)(6) 2025.

• 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 (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: 22415579
• Report Number: 2124215-2025-44855
• Device Sequence Number: 8294175
• Product Code: DRE
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• 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): 08/06/2025

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
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 159 KG
• Patient Race: White