MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Access Solution; Catheter, Septostomy

Model Number	VXSK0122
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith efforts to obtain additional information are in progress.If additional information received, a supplemental report will be filed.
Event or Problem Description
It was reported that during cardiac catherization procedure a versacross access solution was selected for use, physician obtained femoral venous access using a 4fr micro sheath.An attempt was made to exchange the 4fr micro sheath for the 8.5 versacross sheath.Tried to remove the wire but it was stuck in the versacross dilator.Thus, had to remove the dilator and open a new versacross to replace.No patient complications reported.

• Brand Name: VersaCross Access Solution
• Common Device Name: Catheter, Septostomy
• 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: 25829196
• Report Number: 2124215-2026-38087
• Device Sequence Number: 13261906
• Product Code: DYB
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)290301(10)39170112
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0039170112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 03/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 178 LB
• Patient Race: White