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

Model Number	VXSK0122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	09/24/2025
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
It was pericardial effusion occurred.The procedure was aborted.It was reported that versacross access solution was selected for laac procedure.During the procedure, the patient was placed under anesthesia, and the procedure was begun.The physician was got an access and asked for 5,000 units of heparin.Transeptal position was viewed in short axis and bicaval views and transeptal was performed in a mid/ inferior position using the versacross transeptal sheath and wire.Post transeptal, the patients experienced a drop in blood pressure with pericardial effusion noted by cardiac imager.Patient was monitored by anesthesia, the physician and cardiac imager.Heparin was reversed with protamine for that physician decided against doing a pericardiocentesis.The procedure was aborted and patient did not receive the watchman implant.The patient is expected to fully be recovered as patient stayed overnight as planned to discharge on (b)(6) 2025.There was a minor pericardial effusion noted prior, noted under the right ventricle on tee.The effusion increased in size after transeptal puncture.The device is not expected to return as discarded.
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.
Event or Problem Description
It was pericardial effusion occurred.The procedure was aborted.It was reported that versacross access solution was selected for laac procedure.During the procedure, the patient was placed under anesthesia, and the procedure was begun.The physician was got an access and asked for 5,000 units of heparin.Transeptal position was viewed in short axis and bicaval views and transeptal was performed in a mid/ inferior position using the versacross transeptal sheath and wire.Post transeptal, the patients experienced a drop in blood pressure with pericardial effusion noted by cardiac imager.Patient was monitored by anesthesia, the physician and cardiac imager.Heparin was reversed with protamine for that physician decided against doing a pericardiocentesis.The procedure was aborted and patient did not receive the watchman implant.The patient is expected to fully be recovered as patient stayed overnight as planned to discharge on (b)(6) 2025.There was a minor pericardial effusion noted prior, noted under the right ventricle on tee.The effusion increased in size after transeptal puncture.The device is not expected to return as discarded.It was further reported that the versacross device was inside the patient body when patient complication begun, they just gone transeptal.The versacross did not malfunction during the procedure.The patient was hospitalized for the standard of care.The patient was discharged the day after the procedure.The patient experienced soft blood pressure at the time of the incident that were supported by anesthesia.The patient was then able to stabilize on their own.

• Brand Name: VERSACROSS 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; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23294735
• Report Number: 2124215-2025-72989
• Device Sequence Number: 21339052
• Product Code: DXF
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280113(10)36094944
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/22/2025

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0036094944
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 01/13/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Race: White