MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0103
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a watchman procedure, a versacross connect laac was selected for use.Upon opening the first versacross connect, the scrub tech and physician was unable to load the wire into the versacross dilator.It appeared that the tip of the dilator looked like it was flared, no mention of slits or tears.Thus, a second versacross was opened which happened to be the same lot number and the same issue occurred.Thus, a third kit with different lot was used and the procedure was completed successfully.No patient complications occurred.The dilator was reshaped.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, a visual inspection of the product return showed damage to the dilator tip.Next, the device passed the flow test.Finally, the dilator failed the wire insertion test, since a difficulty was noted during backloading of wire due to reduced lumen at dilator tip.The reported allegation is confirmed through product return testing.
Event or Problem Description
It was reported that during a watchman procedure, a versacross connect laac was selected for use.Upon opening the first versacross connect, the scrub tech and physician was unable to load the wire into the versacross dilator.It appeared that the tip of the dilator looked like it was flared, no mention of slits or tears.Thus, a second versacross was opened which happened to be the same lot number and the same issue occurred.Thus, a third kit with different lot was used and the procedure was completed successfully.No patient complications occurred.The dilator was reshaped.The device is expected to be returned for analysis.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 23110680
• Report Number: 2124215-2025-66074
• Device Sequence Number: 9832618
• Product Code: DRE
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)280526(10)36732850
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 11/19/2025

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: VXAK0103
• Device Catalogue Number: VXAK0103
• Device Lot Number: 0036732850
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White