inforMED
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

Model number

VXAK0041

Catalog 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.