MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number	VMFD011223
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a thrombus was present.During a left atrial appendage closure (laac) procedure, a versacross connect access solution kit was selected for use.The physician obtained femoral access and a full dose heparin was given to the patient.The intracardiac echocardiography (ice) catheter was inserted to get baseline appendage measurements, however a clot seemed to be noted in the left atrial appendage (laa) when looking from the right ventricular.Then, a transesophageal echocardiogram (tee) probe was dropped to clear the appendage.At this time, the physician aspirated on versacross dilator and pulled out the clot.The appendage was cleared, and procedure continued with no issues.The physician felt confident that it was appropriate to continue procedure once he had safely aspirated and re-flushed versacross system and continued to use the same dilator and watchman sheath.The device is not expected to be returned for analysis (disposed).The physician did not state specifically that he felt that the versacross devices contributed to the thrombus formation.
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: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 19660193
• Report Number: 2124215-2024-40809
• Device Sequence Number: 17896931
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 07/02/2024

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: 09/21/2026
• Device Lot Number: VMFD011223
• 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: 06/13/2024
• Initial Report FDA Received Date: 07/02/2024
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Male