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

Model Number	VSTK0121
Medical Device Problem Codes	Nonstandard Device (1420); Material Perforation (2205); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.If there is any further relevant information received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a farawave pulmonary vein isolation and posterior wall isolation procedure to treat an atrial fibrillation, a torflex sheath was selected for use.Following transseptal puncture with the rf wire, the physician met significant resistance attempting to cross the septum with the sheath and was unable to successfully cross with sheath and dilator.A new transeptal puncture was attempted at three separate locations, but it continued to be unsuccessful when attempting to cross.It was attempted to dilate transeptal location with non-boston scientific (bsc) catheter, but it was still unsuccessful.Torflex sheath and dilator was exchanged for non-bsc sheath, and upon examining the torflex sheath, the physician noticed the tip of the sheath was split and broken.The septum was successfully crossed with the non-bsc sheath sheath and dilator.The non-bsc sheath was then exchanged for a faradrive sheath and procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
B5: describe event or problem- it was further reported that a versacross steerable sheath was selected for use as opposed to the previously reported toflex was used.The summary is updated and corrected.
Event or Problem Description
It was reported that during a farawave pulmonary vein isolation and posterior wall isolation procedure to treat an atrial fibrillation, a torflex sheath was selected for use.Following transseptal puncture with the rf wire, the physician met significant resistance attempting to cross the septum with the sheath and was unable to successfully cross with sheath and dilator.A new transeptal puncture was attempted at three separate locations, but it continued to be unsuccessful when attempting to cross.It was attempted to dilate transeptal location with non-boston scientific (bsc) catheter, but it was still unsuccessful.Torflex sheath and dilator was exchanged for non-bsc sheath, and upon examining the torflex sheath, the physician noticed the tip of the sheath was split and broken.The septum was successfully crossed with the non-bsc sheath sheath and dilator.The non-bsc sheath was then exchanged for a faradrive sheath and procedure was completed.No patient complications were reported.It was further reported that a versacross steerable sheath was selected for use as opposed to the previously reported toflex was used.The tip was inspected prior to use.Sheath insertion into the vasculature was attempted prior to seeing tip damage.An introducer was used.Resistance was encountered during vascular insertion with the sheath.The reported issues was pushing the sheath and dilator across and no issues were the rf wire were noted.The sheath and dilator would not cross the septum.The procedure was completed using a non-bsc sheath sheath and then exchange for a faradrive sheath.

• 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; 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: 24778774
• Report Number: 2124215-2026-18192
• Device Sequence Number: 21313680
• Product Code: DYB
• UDI-Device Identifier: 00685447019701
• UDI-Public: (01)00685447019701(17)281116(10)38321942
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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: VSTK0121
• Device Catalogue Number: VSTK0121
• Device Lot Number: 0038321942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 05/29/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/21/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO VIZIGO SHEATH.; CARTO VIZIGO SHEATH.; CARTO VIZIGO SHEATH.; WEBSTER CS CATHETER.; WEBSTER CS CATHETER.; WEBSTER CS CATHETER.
• Patient Sex: Unknown