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

Model Number	VXAK0001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a versacross connect access solution was selected for use for a watchman laa closure.The versa-cross connect dilator got damaged during procedure right before we were about to go transseptal.Another kit was used to complete the procedure.No patient complications were reported.The procedure was completed successfully.The product will not return for investigation since it was discarded.
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 for a watchman laa closure.The versa-cross connect dilator got damaged when trying to get it out of the package (it is broken).It was needed to open another kit to complete the procedure.No patient complications were reported.The procedure was completed successfully.The product will not return for investigation.06apr2023 received response for gfe: the event happened right before we got started on a watchman procedure on (b)(6).It's happened about 2:19 pm.It happened during procedure right before we were about to go transseptal.There were no patient complications.Yes, the procedure was completed successfully.We just had to open another kit and they would like to have the other kit replaced.No, the device cannot be returned because it was discarded.
Additional Manufacturer Narrative
A supplemental report is being filed to correct the pro-code for dilator, vessel, for percutaneous catheterization.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 degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16809888
• Report Number: 2124215-2023-17257
• Device Sequence Number: 20381054
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 08/31/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2025
• Device Model Number: VXAK0001
• Device Lot Number: VMFC211222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown