MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS STEERABLE ACCESS SOLUTION; PERCUTANEOUS ATRIAL CATHETER KIT

Model Number	VSTK0122
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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
It was reported that a versacross steerable access solution was selected for use in a paroxysmal atrial fibrillation procedure.During the procedure, dilator was withdrawn from the sheath and wire was then readvanced, but dilator was unable to pass beyond the tip of the sheath.It appears that wire entered an irrigation hole at the distal end of the sheath, and dilator followed into the irrigation port.Sheath and dilator were removed from the body, and it was found that distal irrigation hole of the sheath was enlarged.At that point, the sheath was replaced and procedure was completed successfully.No patient complication was reported.The sheath is not expected to be return for analysis as it was disposed.
Additional Manufacturer Narrative
The reported allegation is not confirmed.The device was not returned to bsc for analysis and no media was provided.Dhr/service history review: a batch review was performed and dhr 0037476279 was reviewed.There were no nonconformances and no rejects associated with the jobs, labeling review: the instructions for use were reviewed and it did not reveal any evidence of device off-label use or failure to follow instructions.There is no evidence that any updates to the document are required at this time.Risk review: the complaint type does not present a new or unanticipated failure type or harm.The device has not been returned to bsc for analysis, and information within the event description is insufficient to confirm the cause with confidence."unable to exclude device problem" was therefore selected.
Event or Problem Description
It was reported that a versacross steerable access solution was selected for use in a paroxysmal atrial fibrillation procedure.During the procedure, dilator was withdrawn from the sheath and wire was then readvanced, but dilator was unable to pass beyond the tip of the sheath.It appears that wire entered an irrigation hole at the distal end of the sheath, and dilator followed into the irrigation port.Sheath and dilator were removed from the body, and it was found that distal irrigation hole of the sheath was enlarged.At that point, the sheath was replaced and procedure was completed successfully.No patient complication was reported.The sheath is not expected to be return for analysis as it was disposed.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• Common Device Name: PERCUTANEOUS ATRIAL CATHETER KIT
• 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: 24251039
• Report Number: 2124215-2026-06157
• Device Sequence Number: 8233730
• Product Code: OFK
• UDI-Device Identifier: 00685447019718
• UDI-Public: (01)00685447019718(17)280730(10)37476279
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 04/07/2026

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: VSTK0122
• Device Catalogue Number: VSTK0122
• Device Lot Number: 0037476279
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown