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

Model Number	VXSK0122
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 the rf wire coating was frayed on the proximal end and a sheath could not be loaded onto it.During a pulse field ablation (pfa) pulmonary vein isolation (pvi) and posterior wall (pw) ablation procedure to treat persistent atrial fibrillation a versacross rf wire was used.The rf wire was prepared and a versacross fixed sheath was advanced into the body over the wire.The transseptal puncture was performed successfully.The versacross sheath was backed out of the patient over the rf wire, and an attempt was made to load the faradrive sheath over the wire, but the faradrive dilator would not engage with the wire.After a second attempt to load the faradrive sheath onto the rf wire it was noticed that the proximal end appeared frayed, and that a piece of the frayed coating could become dislodged and embolize if attempts if a sheath were forced over it.Sterile clamps were used attempting to remove the frayed coating, but this was unsuccessful and only further mangled the coating.Rather than removing the rf wire and losing transseptal access, a decision was made to use non-sterile wire cutters to clip the frayed end of the wire off entirely.The proximal end of the rf wire was cleaned with a sterilizing cleaner, and prophylactic antibiotics were administered to the patient due to the compromised sterility of the wire.The exchange for the faradrive sheath was successful after this and the procedure was able to be completed.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The versacross rf wire was returned to boston scientific for analysis.The proximal end was snipped off and exhibited damaged ptfe.The distal end displayed clear signs of use and charring on the rf wire.The dilator was attempted to be inserted over the proximal end; however, there was resistance and dilator was not able to advance.The reported observations were confirmed by the analysis results.
Event or Problem Description
It was reported that the rf wire coating was frayed on the proximal end and a sheath could not be loaded onto it.During a pulse field ablation (pfa) pulmonary vein isolation (pvi) and posterior wall (pw) ablation procedure to treat persistent atrial fibrillation a versacross rf wire was used.The rf wire was prepared and a versacross fixed sheath was advanced into the body over the wire.The transseptal puncture was performed successfully.The versacross sheath was backed out of the patient over the rf wire, and an attempt was made to load the faradrive sheath over the wire, but the faradrive dilator would not engage with the wire.After a second attempt to load the faradrive sheath onto the rf wire it was noticed that the proximal end appeared frayed, and that a piece of the frayed coating could become dislodged and embolize if attempts if a sheath were forced over it.Sterile clamps were used attempting to remove the frayed coating, but this was unsuccessful and only further mangled the coating.Rather than removing the rf wire and losing transseptal access, a decision was made to use non-sterile wire cutters to clip the frayed end of the wire off entirely.The proximal end of the rf wire was cleaned with a sterilizing cleaner, and prophylactic antibiotics were administered to the patient due to the compromised sterility of the wire.The exchange for the faradrive sheath was successful after this and the procedure was able to be completed.No patient complications were reported.The device is expected to be returned for analysis.

• Brand Name: VERSACROSS 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; 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: 23777690
• Report Number: 2124215-2025-90333
• Device Sequence Number: 10345449
• Product Code: OFK
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280618(10)37517260
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/23/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0037517260
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown