MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number	VXSK0122
Medical Device Problem Codes	Nonstandard Device (1420); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
During an atrial fibrillation procedure, a versacross access solution was selected for use.The versacross access solution was advanced into the superior vena cava and the sheath/dilator was loaded onto the wire.The physician was able to advance the dilator into the femoral access site but got stuck at the sheath/dilator transition and could not advance further.The sheath was removed from the wire and it was observed that the tip of the sheath was stretched and buckling backwards from the dilator.A new versacross kit was opened and the new sheath was able to advance through the access site easily.The device will not be available for return due to disposal.
Event or Problem Description
During an atrial fibrillation procedure, a versacross access solution was selected for use.The versacross access solution was advanced into the superior vena cava and the sheath/dilator was loaded onto the wire.The physician was able to advance the dilator into the femoral access site but got stuck at the sheath/dilator transition and could not advance further.The sheath was removed from the wire and it was observed that the tip of the sheath was stretched and buckling backwards from the dilator.A new versacross kit was opened and the new sheath was able to advance through the access site easily.The device will not be available for return due to disposal.
Additional Manufacturer Narrative
Correction to d: suspect medical device (d1, d2a, d2b, 510k) to versacross transseptal sheath.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• 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: 23804064
• Report Number: 2124215-2025-90852
• Device Sequence Number: 20754728
• Product Code: DYB
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280618(10)37557569
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 0037557569
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown