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

Lot Number	VMFD250923
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/10/2024
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
It was reported that a versacross connect access solution was selected for use during a watchman procedure.A pericardial effusion was reported post procedure.After a successful watchman flx implant, a small pericardial effusion (pe) was found on the anterior side of the heart be transesophageal echocardiogram (tee).There were four (4) attempts required to track up / drop down into position on septum before transseptal was performed.The patient was tapped and transferred to the floor in stable condition.Thus, the patient was discharged next day next day and in good condition.The device is not expected to be returned for analysis (disposed).No pericardial effusion was noted prior to the procedure.No other adverse event or device malfunctions were reported.It was deemed that the pe happened probably during transseptal.In the physician's opinion, the versacross rf wire caused the pericardial effusion.The patient was under eliquis.The act was 300+.

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18615465
• Report Number: 2124215-2024-02913
• Device Sequence Number: 2441452
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/31/2024

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 Expiration Date: 07/17/2026
• Device Lot Number: VMFD250923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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
• Patient Sex: Female