MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VersaCross Connect LAAC Access Solution; Dilator, Vessel, For Percutaneous Catheterization

Model Number	VXAK0007
Medical Device Problem Codes	Off-Label Use (1494); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/25/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient death occurred.During a stroke prevention watchman left atrial appendage closure (laac) procedure, a versacross connect access solution rf wire and dilator were selected for transseptal access.During positioning prior to transseptal puncture (tsp), the physician positioned too low on the septum and was advised by the clinical specialist to return to the superior vena cava and reattempt positioning using the wire; however, this recommendation was not followed.The echo cardiologist also cautioned that the needle orientation appeared directed toward the aorta.Tsp was subsequently performed.After puncture, an attempt was made to advance the versacross wire into the left upper pulmonary vein (lupv), but visualization was lost on echocardiography.Although the wire appeared to be in position, the physician removed the versacross wire and replaced it with a standard 0.035-inch j-tip wire against the clinical specialist's advice.A pre-existing pericardial effusion of approximately 10 mm was present before the procedure and following tsp the effusion began to enlarge to more than twice its original size.As the effusion increased, hemodynamic compromise developed and dropping pressures.The anesthetist, clinical specialist, and echo cardiologist recommended pericardiocentesis, but no immediate intervention occurred.Cardioversion was performed, the patient's pressures dropped to near flatline, prompting cpr.A pericardial drain was eventually placed with autotransfusion, yielding dark red fluid.The watchman procedure was aborted without device deployment.The patient was transferred to surgery, where findings included a hematoma near the aorta, a hematoma on the posterior wall of the left atrium, and bleeding into the right chest cavity.Surgical repair was performed.The complication profile included pericardial effusion, cardiac tamponade, suspected perforation, hemorrhage, hemodynamic collapse, cardiac arrest, and death.The patient did not recover following surgery and died the following day.No device malfunction was identified with the trusteer access system or versacross connect devices.An autopsy is pending; however, the implanting physician indicated that a perforation occurred through the posterior wall of the left atrium.Procedural factors may have contributed, including not leading with the versacross wire when re-engaging the svc, removing the versacross wire against recommendations, and substituting a standard j-tip wire while positioned near the left atrial back wall.It is suspected that removal of the versacross wire may have allowed the trusteer sheath to advance forward, potentially causing the perforation.The patient's death occurred within 24 hours of the procedure and was reported the following morning.
Additional Manufacturer Narrative
H6: impact codes - updated.
Event or Problem Description
It was reported that patient death occurred.During a stroke prevention watchman left atrial appendage closure (laac) procedure, a versacross connect access solution rf wire and dilator were selected for transseptal access.During positioning prior to transseptal puncture (tsp), the physician positioned too low on the septum and was advised by the clinical specialist to return to the superior vena cava and reattempt positioning using the wire; however, this recommendation was not followed.The echo cardiologist also cautioned that the needle orientation appeared directed toward the aorta.Tsp was subsequently performed.After puncture, an attempt was made to advance the versacross wire into the left upper pulmonary vein (lupv), but visualization was lost on echocardiography.Although the wire appeared to be in position, the physician removed the versacross wire and replaced it with a standard 0.035-inch j-tip wire against the clinical specialist's advice.A pre-existing pericardial effusion of approximately 10 mm was present before the procedure and following tsp the effusion began to enlarge to more than twice its original size.As the effusion increased, hemodynamic compromise developed and dropping pressures.The anesthetist, clinical specialist, and echo cardiologist recommended pericardiocentesis, but no immediate intervention occurred.Cardioversion was performed, the patient's pressures dropped to near flatline, prompting cpr.A pericardial drain was eventually placed with autotransfusion, yielding dark red fluid.The watchman procedure was aborted without device deployment.The patient was transferred to surgery, where findings included a hematoma near the aorta, a hematoma on the posterior wall of the left atrium, and bleeding into the right chest cavity.Surgical repair was performed.The complication profile included pericardial effusion, cardiac tamponade, suspected perforation, hemorrhage, hemodynamic collapse, cardiac arrest, and death.The patient did not recover following surgery and died the following day.No device malfunction was identified with the trusteer access system or versacross connect devices.An autopsy is pending; however, the implanting physician indicated that a perforation occurred through the posterior wall of the left atrium.Procedural factors may have contributed, including not leading with the versacross wire when re-engaging the svc, removing the versacross wire against recommendations, and substituting a standard j-tip wire while positioned near the left atrial back wall.It is suspected that removal of the versacross wire may have allowed the trusteer sheath to advance forward, potentially causing the perforation.The patient's death occurred within 24 hours of the procedure and was reported the following morning.
Event or Problem Description
It was reported that patient death occurred.During a stroke prevention watchman left atrial appendage closure (laac) procedure, a versacross connect access solution rf wire and dilator were selected for transseptal access.During positioning prior to transseptal puncture (tsp), the physician positioned too low on the septum and was advised by the clinical specialist to return to the superior vena cava and reattempt positioning using the wire; however, this recommendation was not followed.The echo cardiologist also cautioned that the needle orientation appeared directed toward the aorta.Tsp was subsequently performed.After puncture, an attempt was made to advance the versacross wire into the left upper pulmonary vein (lupv), but visualization was lost on echocardiography.Although the wire appeared to be in position, the physician removed the versacross wire and replaced it with a standard 0.035-inch j-tip wire against the clinical specialist advice.A pre-existing pericardial effusion of approximately 10 mm was present before the procedure and following tsp the effusion began to enlarge to more than twice its original size.As the effusion increased, hemodynamic compromise developed and dropping pressures.The anesthetist, clinical specialist, and echo cardiologist recommended pericardiocentesis, but no immediate intervention occurred.Cardioversion was performed, the patient's pressures dropped to near flatline, prompting cpr.A pericardial drain was eventually placed with autotransfusion, yielding dark red fluid.The watchman procedure was aborted without device deployment.The patient was transferred to surgery, where findings included a hematoma near the aorta, a hematoma on the posterior wall of the left atrium, and bleeding into the right chest cavity.Surgical repair was performed.The complication profile included pericardial effusion, cardiac tamponade, suspected perforation, hemorrhage, hemodynamic collapse, cardiac arrest, and death.The patient did not recover following surgery and died the following day.No device malfunction was identified with the trusteer access system or versacross connect devices.An autopsy is pending; however, the implanting physician indicated that a perforation occurred through the posterior wall of the left atrium.Procedural factors may have contributed, including not leading with the versacross wire when re-engaging the svc, removing the versacross wire against recommendations, and substituting a standard j-tip wire while positioned near the left atrial back wall.It is suspected that removal of the versacross wire may have allowed the trusteer sheath to advance forward, potentially causing the perforation.The patient's death occurred within 24 hours of the procedure and was reported the following morning.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of e0619 pericardial effusion, e0605 cardiac tamponade, e0604 cardiac perforation, e0506 hemorrhage/blood loss/bleeding, e0602 cardiac arrest, e0505 hematoma, e2321 low blood pressure/ hypotension, a0709 device sensing problem, and a2304 off-label use.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Risk review a risk review performed for the faradrive device confirmed that the events of e0619 pericardial effusion, e0605 cardiac tamponade, e0604 cardiac perforation, e0506 hemorrhage/blood loss/bleeding, e0602 cardiac arrest, e0505 hematoma, e2321 low blood pressure/ hypotension, a0709 device sensing problem, and a2304 off-label use are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event, known inherent risk of device and supporting evidence that came to this conclusion.Boston scientifics investigation findings were the reported event appears most consistent with procedural and user-related factors.Specifically, the procedure reportedly continued despite recommendations to reposition prior to transseptal puncture, concerns regarding puncture location and orientation, and loss of visualization during device advancement contrary to recommendations provided during the procedure.These actions may have contributed to unintended injury, resulting in complications and ultimately the patient passing away.The available information suggests that procedural factors and deviation from recommended device use contributed to the reported event.The adverse events were also known inherent risks of device.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• 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): 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 ; +1(651)440-0979
• MDR Report Key: 25597926
• Report Number: 2124215-2026-33367
• Device Sequence Number: 12123655
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: (01)00685447012597(17)270430(10)34752877
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0007
• Device Catalogue Number: VXAK0007
• Device Lot Number: 0034752877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 08/23/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/17/2026; 09/10/2026
• Date Device Manufactured: 04/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 J TIP GUIDEWIRE; 0.035 J tip guidewire; 6F PIGTAIL CATHETER; 6F Pigtail Catheter; VERSACROSS CONNECT RF WIRE (BAYLIS); VersaCross Connect RF Wire (Baylis); WATCHMAN TRUSTEER ACCESS SYSTEM - BSC; WATCHMAN TruSteer Access System - BSC
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Death
• Patient Age: 74 YR
• Patient Sex: Male