inforMED
MalfunctionDWS

SCANLAN® VASCULAR TUNNELER SHEATHS AND BULLET TIPS

Received Jan 12, 2026 · Event occurred Oct 15, 2025

Report 24034547 · MDR key 24034547

Device

Generic name

Instruments, Surgical, Cardiovascular

Model number

9009-18

Catalog number

9009-18

Lot number

8339902

Patient

79 YR · Male

  • Hemorrhage/Blood Loss/Bleeding
  • Foreign Body In Patient

Narrative

Description of Event or Problem

TUNNEL CATH WAS BEING USED DURING THE PROCEDURE WHEN A SMALL PIECE OF SILICONE BROKE OFF IN THE LEG. IT IS UNABLE TO BE DETECTED VIA X-RAY. THE DR. WENT IN VIA SCOPE AND CANNOT FIND THE PIECE. ROUGHLY 20MLS OF BLEEDING TOOK PLACE AS A RESULT TO LOCATE THE TIP THROUGH CREATING NEW TUNNELS. THE PROCEDURALIST NOTED THAT THE PATIENT HAD A CONTRACTURE OF THE KNEE RELATED TO A PREVIOUS KNEE SURGERY. SHE STATED THAT WHEN TUNNELING IT IS DONE ANATOMICALLY AND IS DEEP IN THE ARTERY IN THE LEG DURING THE PROCEDURE. SHE ALSO NOTED THAT SHE COULD FEEL RUBBING OF THE METAL ROD AGAINST THE KNEE JOINT / CONTRACTURE WHEN TUNNELING BACK AND FORTH.