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

Model Number	VLAK0010
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that versacross large access solution was selected for use.During the procedure, it was mentioned that when the bmc rf generator was turned on and attempt were made for transseptal, but it failed.It crossed in the second attempt and the sheath was advanced.When the physician tried to pull back the versacross rf wire into the dilator, it felt it got stuck into the dilator (but not into the patient body), so the versacross rf wire was readvanced into the dilator.No visible obstruction was noted when the versacross rf wire when visualized on intracardiac echocardiography (ice) in left superior pulmonary vein (lspv).The physician applied force back to the dilator, and the versacross rf wire was noted to be knotted at its tip.Thus, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.No other issue was reported during transseptal portion nor preparation.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected with vhx inspection, and the tip of the rf wire was noted to be knotted.The reported allegations related to the knotting is confirmed based on the returned product.The reported allegation related to difficulty crossing was not confirmed as successful crossing on the second attempt suggests the knotting did not contribute to the difficulty, as there is no evidence available to confirm the issue.
Event or Problem Description
It was reported that versacross large access solution was selected for use.During the procedure, it was mentioned that when the bmc rf generator was turned on and attempt were made for transseptal, but it failed.It crossed in the second attempt and the sheath was advanced.When the physician tried to pull back the versacross rf wire into the dilator, it felt it got stuck into the dilator (but not into the patient body), so the versacross rf wire was readvanced into the dilator.No visible obstruction was noted when the versacross rf wire when visualized on intracardiac echocardiography (ice) in left superior pulmonary vein (lspv).The physician applied force back to the dilator, and the versacross rf wire was noted to be knotted at its tip.Thus, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.No other issue was reported during transseptal portion nor preparation.

• Brand Name: VERSACROSS LARGE 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20901963
• Report Number: 2124215-2024-78073
• Device Sequence Number: 5006017
• Product Code: DXF
• UDI-Device Identifier: 00685447017530
• UDI-Public: 00685447017530
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 01/30/2025

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: VLAK0010
• Device Catalogue Number: VLAK0010
• Device Lot Number: 0035019901
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/18/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown