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

Model Number	VXSK0023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/30/2024
Type of Reportable Event	Death
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 reported a patient death occurred.The procedure was cancelled.During a watchman flx pro procedure, a versacross access solution kit was selected for use.A trace effusion was noted prior to procedure.The physician obtained right femoral vein access and an 18guage sheath was placed.The versacross sheath was inserted.The physician dropped below the septum on first attempt, so it was re-attempted to re-wire the superior vena cava (svc) to come back down to the septum.The transseptal puncture was performed and the versacross sheath was exchanged for the watchman trusteer sheath over the wire.A pigtail catheter went in over the wire.At this point, an effusion was noted.Auto transfusion began with that pigtail catheter while a pericardiocentesis was performed.After that there were two pigtail catheters placed in the pericardial space.12 units of packed red blood cells (prbcs), 8 units of fresh frozen plasma (ffp) and 1 unit of platelets were given and the patient was taken to the operating room (or).The patient arrested before getting transferred the or table, patient chest was opened but were unable to resuscitate.It was determined the cause of death was due to perforation at the back wall of the heart leading to pericardial effusion, cardiac tamponade.The device is not expected to be returned for analysis.It was further confirmed via gfe dated 10jan2025, there was no imaging/visualization issues noted.The tsp was was difficult because of the reachability.The physician brought the sheath out over the wire and put more of a bend on the versacross and went back in to the svc and back down.The tsp was very inferior and posterior.The perforation could have partially caused by the wire however the physician put the trusteer over the wire and into the pericardial space.There was no malfunction with the versacross system.Activated clotting time (act) greater than 400 with an inr of 2.5 on case day.

• 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; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21197451
• Report Number: 2124215-2025-01600
• Device Sequence Number: 7559439
• Product Code: DXF
• UDI-Device Identifier: 00685447007449
• UDI-Public: 00685447007449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/21/2025

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: VXSK0023
• Device Catalogue Number: VXSK0023
• Device Lot Number: 0034870484
• 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: 12/30/2024
• Initial Report FDA Received Date: 01/21/2025
• Date Device Manufactured: 07/04/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White