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

Model Number	VXSK0033
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/20/2025
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.A separated report for the versacross rf wire will be submitted.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a pericardial effusion (pe) was noted.During a left atrial appendage closure (laac) procedure, a versacross access solution was selected for use.There was a trace effusion noted before the procedure started and it was located at the apex of the heart.The versacross wire was inserted in the superior vena cava (svc), with the sheath to follow.The physician brought the whole system down onto the septum in order to get in the right position to cross and go into the left atrium (la).In the process of trying to get the correct placement on the septum the access system was placed in the right atrial appendage and then dropped onto the septum.The physician went to cross the septum and head into the left atrium.Once across the left atrium, the rf wire was inserted into the left atrial appendage and the versacross system was taken out, next the watchman double curve sheath was inserted.Once the double curve was inserted the non-boston scientific pigtail catheter over the rf wire and the wire was taken out.La pressure was obtained at this point, and a contrast shot was taken of the left atrial appendage to determine what size watchman device.The device was prepped, then inserted into the watchman sheath and deployment into the left atrial appendage.The device was deployed into the left atrial appendage.Once the device met the pass criteria, it was released.The transesophageal echocardiogram (tee) physician performed a sweep of the device and the effusion and the effusion that was noted before the procedure had discovered to have had an increase amount of fluid.The physician performed a pericardial tap and drained the fluid off.The fluid that was taken out of the patient was a duller red color and about 450ml of fluid was taken out.The patient was sent to the intensive care unit (icu) to have further evaluation and monitoring of the effusion.The patient was expected to fully recover and was discharged.The device is not expected to be returned for analysis (disposed).In the physician opinion, the pe occurred when trying to cross the septum, into the right atrium, at the beginning of the procedure.The patient was not on warfarin.The patient was on eliquis at the time of the procedure.The versacross dilator and sheath was tracked up and down the svc and inferior vena cava (ivc) to make sure there was proper location on the septum.The patient remained stable the whole time during the procedure and never showed any signs or symptoms.There was a difficulty with the tsp workflow.In order to get more inferior - mid (location on the septum), the sheath would fall off the septum and the rf wire would have to be advanced into the svc in order to get back to where the sheath and dilator could be in proper position on the septum.There were times that the wire or the dilator would grab hold of the right atrial appendage.The versacross dilator, sheath, wire did not cause malfunction during the procedure.The anatomy of the patient's heart made it a little difficult to make sure to get in the proper placement on the septum.Half of the heparin dose was given prior to tsp, and the other half was given after tsp.10 minutes after the final heparin dose was given an act sample was given to the staff to check.Within 5 minutes of the sample given the act resulted at 334.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22170061
• Report Number: 2124215-2025-37658
• Device Sequence Number: 7957557
• Product Code: DYB
• UDI-Device Identifier: 00685447017363
• UDI-Public: (01)00685447017363
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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
• Report Date (Section B): 06/09/2025

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: VXSK0033
• Device Catalogue Number: VXSK0033
• Device Lot Number: 0034801943
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 06/11/2024
• 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; Life Threatening; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White