MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Dilator, Vessel, For Percutaneous Catheterization

Model Number	VXAK0107
Medical Device Problem Codes	Material Perforation (2205); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction

• Brand Name: VersaCross Connect LAAC Access Solution
• Common Device Name: Dilator, Vessel, For Percutaneous Catheterization
• 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 ; +1(651)440-0979
• MDR Report Key: 50228391
• Report Number: 2124215-2026-42734
• Device Sequence Number: 10273590
• Product Code: DRE
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497(17)290316(10)39519771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 09/28/2026

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: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0039519771
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female