MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT ACCESS SOLUTION FOR CARTO VIZIGO SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number	0034907316
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ventricular tachycardia ablation procedure, a versacross connect access solution for carto vizigo sheath was selected for use.It was noted that the end of dilator broke off when the wire was removed and flush connected to it.The luer of the dilator was completely detached.Thus, device was replaced and no patient complications reported.The device is not expected to be returned for analysis (disposed).

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR CARTO VIZIGO SHEATH
• 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 ; 6514400979
• MDR Report Key: 24241557
• Report Number: 2124215-2026-05902
• Device Sequence Number: 9184114
• Product Code: DRE
• UDI-Device Identifier: 00685447020080
• UDI-Public: (01)00685447020080(17)270823(10)34907316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K241720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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 Lot Number: 0034907316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 08/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown