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

Model Number	VXAK0109
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Codes	Hemoptysis (1887); Pain (1994)
Date of Event	10/20/2025
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.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported the patient experienced pain.During an left atrial appendage occlusion (laao) procedure, a versacross connect laac was selected for use.The physician went up with intracardiac echocardiography (ice) catheter and versacross connect.The patient's heart was very rotated and patient was yelling out in pain the whole time with every manipulation of the catheter.The first attempt for transseptal was attempted but was unsuccessful.It was then attempted to reposition and did a successful transseptal.After the second transseptal and crossing with sheath and ice, the patient began to cough up blood.The physician paused the procedure.Suction to get blood was performed and a wedge under the patient was placed.After a few minutes the patient seem to stabilize and the physician decided to proceed and complete procedure.The patient is expected to recover fully.The device is not expected to be returned for analysis (disposed).
Event or Problem Description
It was reported the patient experienced pain.During an left atrial appendage occlusion (laao) procedure, a versacross connect laac was selected for use.The physician went up with intracardiac echocardiography (ice) catheter and versacross connect.The patient's heart was very rotated and patient was yelling out in pain the whole time with every manipulation of the catheter.The first attempt for transseptal was attempted but was unsuccessful.It was then attempted to reposition and did a successful transseptal.After the second transseptal and crossing with sheath and ice, the patient began to cough up blood.The physician paused the procedure.Suction to get blood was performed and a wedge under the patient was placed.After a few minutes the patient seem to stabilize and the physician decided to proceed and complete procedure.The patient is expected to recover fully.The device is not expected to be returned for analysis (disposed).It was further reported that the patient was on non-ga.Transseptal workflow was difficult due to position of septum, being able to tent, had to go up multiple times and attempt to place curve on dilator/sheath multiple times.Patient was hemodynamically stable otherwise.Patient was discharged same day with no other issues, coughing up blood stopped prior to case ending and did not occur again.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated fields - describe event or problem (b5), in section b - adverse event or product problem, common device name (d2a), pro code (product code) (d2b), in section d - suspect medical device and device codes (f10 and h6), in sections f - for use by uf/importer and h - device manufacturers only.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23544913
• Report Number: 2124215-2025-82632
• Device Sequence Number: 21153148
• Product Code: DRE
• UDI-Device Identifier: 00685447019503
• UDI-Public: (01)00685447019503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0109
• Device Catalogue Number: VXAK0109
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown