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

Model Number	VXAK0041
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire coating issue occurred.It was reported that a versacross mechanical guidewire was selected for pulmonary vein isolation (pvi), pulmonary wall isolation (pwi), cavotricuspid isthmus (cti) and mitral isthmus (mi) to treat atrial fibrillation (afib).Prior to procedure, upon opening package, the guidewire was bent or kinked and frayed.Guidewire was replaced and procedure was completed without patient complications.Product return is not expected as it was disposed.It was further informed that the damage was observed in the mechanical guidewire and the coating was scraped.The fraying occurred in the proximal end of the guidewire.Additionally, there were no patient complication's reported, it was a good patient outcome.

• Brand Name: VersaCross Connect Access Solution for FARADRIVE
• 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: 50819154
• Report Number: 2124215-2026-49954
• Device Sequence Number: 16114176
• Product Code: DRE
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)290608(10)85052961
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K233647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0085052961
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 06/09/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown