MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0103
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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
It was reported that during the watchman procedure to treat left atrial appendage closure versacross connect laac access solution kit was selected for use.It has been mentioned that versacross connect was placed in the watchman sheath and versacross wire was used to get to the superior vena cava (svc).The catheter was not able to reach the fossa.The physician then removed to the dilate and reshaped the connect dilator to get to fossa.The versacross connect was put back in the watchman fxd double curve sheath and reattempted to engage the septum.The physician was able to engage the septum slightly and tried to use rf energy with the versacross wire to cross.A metal contact on the generator was received, and the physician then tried to cross again with the wire but ended up deciding to switch to an nrg with an sl1 sheath.The double curve with the connect and wire was removed from the body and it was discovered that the tip of the versacross pigtail had the coating peeled off.The insulation stripped at the proximal end of the wire.The dilator was backloaded onto the wire inside the patient.The physician removed the dilator only with the wire still inside the body reshaped and place the dilator back in.The physician was able to cross with nrg and complete the watchman procedure.No patient complications have been reported.The product is not expected to be return as it was disposed.
Additional Manufacturer Narrative
Device technical analysis.It was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.The reported allegation was able to be confirmed via media provided.
Event or Problem Description
It was reported that during the watchman procedure to treat left atrial appendage closure versacross connect laac access solution kit was selected for use.It has been mentioned that versacross connect was placed in the watchman sheath and versacross wire was used to get to the superior vena cava (svc).The catheter was not able to reach the fossa.The physician then removed to the dilate and reshaped the connect dilator to get to fossa.The versacross connect was put back in the watchman fxd double curve sheath and reattempted to engage the septum.The physician was able to engage the septum slightly and tried to use rf energy with the versacross wire to cross.A metal contact on the generator was received, and the physician then tried to cross again with the wire but ended up deciding to switch to an nrg with an sl1 sheath.The double curve with the connect and wire was removed from the body and it was discovered that the tip of the versacross pigtail had the coating peeled off.The insulation stripped at the proximal end of the wire.The dilator was backloaded onto the wire inside the patient.The physician removed the dilator only with the wire still inside the body reshaped and place the dilator back in.The physician was able to cross with nrg and complete the watchman procedure.No patient complications have been reported.The product is not expected to be return as it was disposed.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• 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: 23959072
• Report Number: 2124215-2026-00286
• Device Sequence Number: 5609917
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)280908(10)37469265
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: VXAK0103
• Device Catalogue Number: VXAK0103
• Device Lot Number: 0037469265
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male