MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Steerable Access Solution; Percutaneous atrial catheter kit

Model Number	VST85-35-BD-71L-D0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
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.
Event or Problem Description
It was reported that during the pulmonary vein isolation to treat atrial fibrillation versacross steerable access solution were selected for use.It has been mentioned that before the insertion stopcock broke off.The procedure was completed using different device (same model).The product is not expected to return as disposed.

• Brand Name: VersaCross Steerable Access Solution
• Common Device Name: Percutaneous atrial catheter kit
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 23638294
• Report Number: 2124215-2025-86126
• Device Sequence Number: 9203954
• Product Code: DYB
• UDI-Device Identifier: 00685447019657
• UDI-Public: (01)00685447019657(17)280716(10)37419902
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: VST85-35-BD-71L-D0
• Device Catalogue Number: VST85-35-BD-71L-D0
• Device Lot Number: 0037419902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown