MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0007
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
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.Initial reporter phone number exceeded character limit: (b)(6).We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a watchman procedure, a versacross connect laac access solution kit was selected for use.The physician was unable to insert the rf wire through the dilator and felt a sharp edge on the wire that prevented from inserting it.Resistance when loading cable through the dilator.Doctor expressed that he felt resistance because he had porosity and an additional sharp texture in the wire.The procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
The device has returned for analysis.Upon receipt at our post market quality assurance laboratory, the rf wire was visually inspected and noted to have insulation bunching on proximal end.No further damages were noted on the wire.The wire was attempted to be inserted into the return dilator and a testing dilator but both were difficult to advance.The device passed inspection of wire body and proximal end outer diameter.The allegation is confirmed as the rf wire was returned to bsc and testing confirmed difficulty to advance and proximal coating bunching.Initial reporter phone number exceeded character limit: (b)(6).We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.Correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e - initial reporter.
Event or Problem Description
It was reported that during a watchman procedure, a versacross connect laac access solution kit was selected for use.The physician was unable to insert the rf wire through the dilator and felt a sharp edge on the wire that prevented from inserting it.Resistance when loading cable through the dilator.Doctor expressed that he felt resistance because he had porosity and an additional sharp texture in the wire.The procedure was completed successfully.No patient complications occurred.The device is not expected to be returned for analysis (disposed).

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22055359
• Report Number: 2124215-2025-32383
• Device Sequence Number: 15247677
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

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 Model Number: VXAK0007
• Device Catalogue Number: VXAK0007
• Device Lot Number: 0035120915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White