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

Lot Number	VMFA210923
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/05/2023
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 thrombosis occurred.During a left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.There were difficulties experienced performing the transseptal puncture and several attempts were made for about thirty minutes before the interatrial septum was successfully crossed.A transesophageal echocardiogram (tee) revealed a free floating thrombus in the right atrium and heparin was administered.Act drawn later result was 308.The left atrial appendage (laa) procedure was successfully completed and the patient discharged the same day.The device is not expected to be returned for analysis.
Event or Problem Description
It was reported that a thrombosis occurred.During a left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.There were difficulties experienced performing the transseptal puncture and several attempts were made for about thirty minutes before the interatrial septum was successfully crossed.A transesophageal echocardiogram (tee) revealed a free floating thrombus in the right atrium and heparin was administered.Act drawn later result was 308.The left atrial appendage (laa) procedure was successfully completed and the patient discharged the same day.The device is not expected to be returned for analysis.
Additional Manufacturer Narrative
"**udi related data quality updates only**.This report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." 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: 18360306
• Report Number: 2124215-2023-72334
• Device Sequence Number: 12740806
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: (01)00685447012573(17)260717(10)VMFA210923
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 08/06/2024

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: VMFA210923
• 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
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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: 85 YR
• Patient Sex: Male