MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number	0033424459
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/22/2024
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
A pericardial effusion (pe) occurred.It was reported that a versacross connect laac access solution was selected for use during a left atrium appendage closure (laac).During the transseptal puncture, it was noted that the versacross rf wire did not track normally into the left atrium (la).Post delivery of watchman device, during routine pericardial sweep, a pericardial effusion was noted around apex of heart and under right atrium, and a pericardiocentesis was done and pericardial drain was placed.The procedure was completed successfully.The patient was hospitalized beyond standard of care and was discharged next day.The device is not expected to be returned for analysis (disposed).No prior effusion was noted prior to the procedure.There is no reason to believe that the versacross wire malfunctioned during the procedure.In the physician's opinion, the versacross rf wire contributed to the event, since during transseptal, it did not track normally into left atrium.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: 20194755
• Report Number: 2124215-2024-56873
• Device Sequence Number: 15395987
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/11/2024

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 Lot Number: 0033424459
• 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: 08/22/2024
• Initial Report FDA Received Date: 09/11/2024
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Race: White