MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0105
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rf wire was received for analysis.Upon receipt at our post market quality assurance laboratory, the rf wire was visually inspected and it was revealed that there was an insulation damage observed along the wire body.There was no damage to distal tip noted.It was further revealed that there was a minor flaring at proximal transition.Residue or damaged polytetrafluoroethylene (ptfe) also observed along mid-body of wire.Grouping of sheared and damaged ptfe located between 84 cm and 88 cm from the proximal end of the wire.Minor delamination of ptfe observed more distal along wire body, 223 cm from proximal end of the wire.The dilator was attempted to be inserted over the proximal end; no resistance was encountered and dilator was able to advance.The dimensional test revealed the wire body outside diameter was out of specification at ptfe shearing but within specification at proximal end of insulation, at minor delamination distally, and at wire body.The reported allegation is confirmed based on the returned device.
Event or Problem Description
Reportable based on analysis completed on 17feb2026.It was reported that during a left atrial appendage occlusion (laao) procedure, a versacross connect laac was selected for use.It was noted during preparation that when it was attempted to load the rf wire into the dilator, it would not advance.Multiple attempts were made by flushing dilator and tilting, but it would not go past the edge.Thus, the device was replaced and the procedure was completed successfully.Issue occurred prior to patient being present.No patient complications occurred.The device is expected to be returned for analysis.However, analysis revealed a very minor flaring at proximal transition and polytetrafluoroethylene (ptfe) shearing observed more distal.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24454990
• Report Number: 2124215-2026-10675
• Device Sequence Number: 10148100
• Product Code: DXF
• UDI-Device Identifier: 00685447019480
• UDI-Public: (01)00685447019480(17)280703(10)37070325
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/26/2026

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: VXAK0105
• Device Catalogue Number: VXAK0105
• Device Lot Number: 0037070325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown