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

Model Number	VXAK0001
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	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect for laac kit was selected for use.A small effusion was noted prior to the procedure.The physician gained femoral access.The watchman trustee access sheath and versacross connect system was inserted for transseptal puncture along with a non-boston scientific intracardiac echocardiography (ice) catheter.The transseptal puncture (tsp) was performed in an inferior/mid anterior position with no issues.The physician attempted crossing the ice catheter into the left atrium, but was unsuccessful and during this attempt, a pericardial effusion was noted on the posterior side of the heart.Pericardial effusion was confirmed via contrast injection showing contrast in the pericardium but not surrounding the left atrial appendage (laa).Patient's blood pressure dropped approximately 20 mm/hg and was maintained with iv fluids.Protamine was given and the watchman sheath was removed to the right side of the heart.The effusion was monitored for forty-five minutes with no increase in size.The physician discontinues the procedure despite the patient remaining stable.The patient also did well overnight after the procedure and was discharged the following day.The device is not expected to be returned for analysis.Act was therapeutic during the procedure.There was no difficulty noted with the transseptal workflow.The tenting was visualized normally.No versacross device malfunctions noted.
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.

• 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20688058
• Report Number: 2124215-2024-71685
• Device Sequence Number: 17949422
• Product Code: DXF
• UDI-Device Identifier: 00685447018339
• UDI-Public: 00685447018339
• 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
• Report Date (Section B): 11/14/2024

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: VXAK0001
• Device Catalogue Number: VXAK0001
• Device Lot Number: 0034184575
• 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: 10/24/2024
• Initial Report FDA Received Date: 11/14/2024
• Date Device Manufactured: 01/04/2024
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: White