MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Dilator, Vessel, For Percutaneous Catheterization

Model Number	VXAK0105
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a thrombus.It was reported that during a watchman flx pro procedure to treat left atrial appendage closure (laac) a versacross connect laac access solution was selected for use for transseptal access.The physician went into the body with the pigtail wire, followed by the double curve watchman sheath and dilator, when waiting to go transseptal it was noticed a clot on the wire.It was noticed the dilator tip was damaged, so it replaced with a new versacross connect.Then went back up and continued the procedure as normal, procedure was completed with no patient consequences observed.The activated clotting time (act) resulted 215 and it was given 10,000 more units of heparin.The irrigation flow was not interrupted during procedure.It was then pulled everything back and flushed everything out.Irrigation flow rate is unknown.Tee was used to rule out thrombus before the procedure.It is unknown if procedure performed was interrupt on anticoagulation regime.Time passed between initial act and last act recorded is unknown.Following act was greater than 400.No fibrin or coagulant was seen at the tip of the catheter.Anticoagulation status before, during and after the procedure is unknown.To resolve the clotting it was given more heparin, then it was pulled everything out, re-flushed everything, replaced dilator and proceeded without issues.Patient was not hospitalized.

• 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 ; +1(651)440-0979
• MDR Report Key: 50936654
• Report Number: 2124215-2026-51748
• Device Sequence Number: 15850379
• Product Code: DRE
• UDI-Device Identifier: 00685447019480
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0105
• Device Catalogue Number: VXAK0105
• Device Lot Number: 0039368403
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Unknown