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
Manufacturer
Scanlan International IncModel number
9009-18Catalog 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.