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

Model Number	VXAK0007
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	07/07/2025
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.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 an aortic hematoma and perforation occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.Transseptal position was observed on transesophageal echocardiogram (tee) and appeared to be mid/mid on the septum.The versacross radio frequency (rf) wire was placed on the septum and rf was applied, but nothing was observed in the left atrium.A new position was obtained, and rf was delivered successfully to cross into the left atrium.Imaging was poor quality.No difficult anatomy and no other complications.After attempting the wire further into the left atrial appendage (laa), change in aortic root was observed by tee imager.The procedure was paused for further evaluation and monitoring of aortic hematoma.The patients' vitals remained stable throughout.It was implanting providers decision to abort procedure to further monitor patient and get cardiac computed tomography (ct) for further diagnosis.During case debrief, case imaging was reviewed and appeared to show the first transseptal attempt crossed into the aorta.The patient was sent to intensive care unit for overnight monitoring and has been discharged.Physician does not believe product contributed to the complication.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
The device did not return for analysis.However, a media was provided but the reported allegations cannot be confirmed based on it.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.Correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e - initial reporter.
Event or Problem Description
It was reported that an aortic hematoma and perforation occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.Transseptal position was observed on transesophageal echocardiogram (tee) and appeared to be mid/mid on the septum.The versacross radio frequency (rf) wire was placed on the septum and rf was applied, but nothing was observed in the left atrium.A new position was obtained, and rf was delivered successfully to cross into the left atrium.Imaging was poor quality.No difficult anatomy and no other complications.After attempting the wire further into the left atrial appendage (laa), change in aortic root was observed by tee imager.The procedure was paused for further evaluation and monitoring of aortic hematoma.The patients' vitals remained stable throughout.It was implanting providers decision to abort procedure to further monitor patient and get cardiac computed tomography (ct) for further diagnosis.During case debrief, case imaging was reviewed and appeared to show the first transseptal attempt crossed into the aorta.The patient was sent to intensive care unit for overnight monitoring and has been discharged.Physician does not believe product contributed to the complication.The device is not expected to be returned for analysis (disposed).

• 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: 22667998
• Report Number: 2124215-2025-52353
• Device Sequence Number: 15355381
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/16/2025

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?: Yes
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male