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

Model Number	VXSK0132
Medical Device Problem Codes	Nonstandard Device (1420); Off-Label Use (1494); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulmonary vein isolation/ posterior wall ablation procedure, a versacross access solution was selected for use.Transseptal was achieved without issue using versacross transseptal sheath.The left atrium pre-map was created.Versacross rf pigtail wire used to exchange transseptal sheath for a non-boston scientific sheath.After removing the non-boston scientific dilator and pigtail wire, physician noticed the end of pigtail wire insulative coating had separated from the actual wire.The procedure was completed and no patient complications occurred.The device has been received at boston scientific's post market laboratory where it is awaiting analysis.
Event or Problem Description
It was reported that during a pulmonary vein isolation/ posterior wall ablation procedure, a versacross access solution was selected for use.Transseptal was achieved without issue using versacross transseptal sheath.The left atrium pre-map was created.Versacross rf pigtail wire used to exchange transseptal sheath for a non-boston scientific sheath.After removing the non-boston scientific dilator and pigtail wire, physician noticed the end of pigtail wire insulative coating had separated from the actual wire.The procedure was completed and no patient complications occurred.The device has been received.
Additional Manufacturer Narrative
The device has returned for analysis.Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and noted to have its single coating tear along entirety of pigtail as well as pigtail shape deformation.Flaring was also observed on proximal end.Finally, the device passed the dimensional test since its shaft was within specifications for outer diameter.The reported allegation of insulation damage is confirmed based on the returned product, although the reported use without the sheath cannot be confirmed.

• Brand Name: VERSACROSS 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: 23687787
• Report Number: 2124215-2025-88141
• Device Sequence Number: 13102740
• Product Code: DXF
• UDI-Device Identifier: 00685447019879
• UDI-Public: (01)00685447019879(17)280624(10)37578043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/20/2026

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: VXSK0132
• Device Catalogue Number: VXSK0132
• Device Lot Number: 0037578043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 65 KG