MalfunctionDXF
VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
Received Jun 18, 2026 · Event occurred May 27, 2026
Report 2124215-2026-32798 · MDR key 25555373
Device
Generic name
Catheter, Septostomy
Manufacturer
Boston Scientific CorporationModel number
VXAK0041Catalog number
VXAK0041
Lot number
0039106669
Product problems
- Material Deformation
- Physical Resistance/Sticking
Patient
79 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR USE FOR ABLATION PROCEDURE. IT WAS REPORTED WHEN THE RF WIRE WAS PULLED BACK INTO THE VERSACROSS DILATOR AFTER PLACING IT IN THE SUPERIOR VENA CAVA (SVC), IT GOT STUCK. PHYSICIAN KEPT TRYING TO RETRACT IT BACK INTO THE DILATOR, EVENTUALLY IT DID REMOVED AND NOTED THAT THE RF WIRE HAS A KNOT AT THE TIP. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH PATIENT COMPLICATIONS.