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

Model Number	VXAK0105
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/22/2025
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.Good faith effort attempts are in progress to try and retrieve additional details regarding the reported event, but further information was unable to be obtained yet.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred that lead to cardiac tamponade.The procedure was cancelled.During a left atrial appendage closure (laac) procedure was being performed, a versacross connect laac kit was selected for use.There was no effusion noted pre procedure.The physician obtained access via the right femoral vein.The watchman sheath and versacross connect system were advanced to the superior vena cave (svc).During pull down from the svc to the inferior vena cava (ivc), the positioning fell off the septum and the physician proceeded to advance the rf wire back up to the svc.The physician started to pull down to the ivc and then fell into the fossa.The physician was tenting inferior and anterior on the septum and energy was delivered.Bubbles were seen in the left atrium (la) but the wire did not advance with ease.The patient had a prior ablation, and the physician believed it went through the iatrogenic atrial septal defect (iasd).The versacross wire was advance, and the dilator was removed, and a non-boston scientific pigtail catheter advance to left atrial appendage (laa).An laa angiogram was performed, and the watchman delivery system (wds) was opened but not prepped.The patient began to become symptomatic, and hemodynamics became unstable.Transesophageal echocardiography (tee) imaging confirmed a 2.9cm circumferential effusion, which was not there pre procedure.Medication was given to keep the patient hemodynamically stable.Pericardiocentesis was initiated and 500cc of blood was pulled off the pericardium and recycled back to the patient via a cell saver.The patient was stable and went to the intensive care unit (icu) with a pericardiocentesis drain bag.The physician will reattempt the laac procedure at a later date.The device is not expected to be returned for analysis (disposed).There is a future plan is re-attempt implant of the laa.The patient was yet hospitalized as of (b)(6) 2025.
Additional Manufacturer Narrative
The device did not return for analysis.However, the reported allegation of pericardial effusion was confirmed via media provided.The other allegations were not able to be confirmed based on media provided.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred that lead to cardiac tamponade.The procedure was cancelled.During a left atrial appendage closure (laac) procedure was being performed, a versacross connect laac kit was selected for use.There was no effusion noted pre procedure.The physician obtained access via the right femoral vein.The watchman sheath and versacross connect system were advanced to the superior vena cave (svc).During pull down from the svc to the inferior vena cava (ivc), the positioning fell off the septum and the physician proceeded to advance the rf wire back up to the svc.The physician started to pull down to the ivc and then fell into the fossa.The physician was tenting inferior and anterior on the septum and energy was delivered.Bubbles were seen in the left atrium (la) but the wire did not advance with ease.The patient had a prior ablation, and the physician believed it went through the iatrogenic atrial septal defect (iasd).The versacross wire was advance, and the dilator was removed, and a non-boston scientific pigtail catheter advance to left atrial appendage (laa).An laa angiogram was performed, and the watchman delivery system (wds) was opened but not prepped.The patient began to become symptomatic, and hemodynamics became unstable.Transesophageal echocardiography (tee) imaging confirmed a 2.9cm circumferential effusion, which was not there pre procedure.Medication was given to keep the patient hemodynamically stable.Pericardiocentesis was initiated and 500cc of blood was pulled off the pericardium and recycled back to the patient via a cell saver.The patient was stable and went to the intensive care unit (icu) with a pericardiocentesis drain bag.The physician will reattempt the laac procedure at a later date.The device is not expected to be returned for analysis (disposed).There is a future plan is re-attempt implant of the laa.The patient was yet hospitalized as of (b)(6) 2025.

• 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): 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: 22005196
• Report Number: 2124215-2025-30380
• Device Sequence Number: 7266649
• Product Code: DXF
• UDI-Device Identifier: 00685447019480
• UDI-Public: (01)00685447019480(17)271212(10)35777023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/19/2025

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: VXAK0105
• Device Catalogue Number: VXAK0105
• Device Lot Number: 0035777023
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White