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

Model Number	VSTK0118
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information and return status was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that versacross steerable access solution was selected during the procedure.It has been mentioned that there was recurring issue where the physician visualized significant amount of air and bubbles every time they attempted to aspirate and introduce catheter through the sheath.This specifically happens when versacross system was used in conjunction with a non-boston scientific mapping catheter.No patient complications reported.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• 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 ; 6514400979
• MDR Report Key: 25458158
• Report Number: 2124215-2026-30920
• Device Sequence Number: 16039176
• Product Code: DYB
• UDI-Device Identifier: 00685447019688
• UDI-Public: (01)00685447019688(17)281027(10)38099621
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2026

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: VSTK0118
• Device Catalogue Number: VSTK0118
• Device Lot Number: 0038099621
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/11/2026; 06/30/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/30/2026; 07/22/2026
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97610227-FA
• Patient Sequence Number: 1
• Patient Sex: Unknown