MalfunctionDXF
VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
Received May 29, 2026 · Event occurred May 4, 2026
Report 2124215-2026-28986 · MDR key 25334475
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Boston Scientific CorporationModel number
VXAK0041Catalog number
VXAK0041
Lot number
0037804034
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE SELECTED FOR AN ATRIAL FIBRILLATION PULMONARY VEIN ISOLATION (PVI) PROCEDURE. DURING PROCEDURE, WHEN THE PHYSICIAN TRIED TO INSERT THE RF WIRE INTO VERSACROSS DILATOR, THE INSULATION PEELED BACK. BEFORE INSERTION NO DAMAGE WAS OBSERVED ON THE DEVICE. THUS THE WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED.