inforMED
OtherEZB

SENSOR

Received Jun 15, 2026 · Event occurred Jun 2, 2026

Report MW5189416 · MDR key 25501212

Device

Generic name

Stylet For Catheter, Gastro-urology

Lot number

38743061

Product problems

  • Material Fragmentation

Patient

86 YR · Male

  • Foreign Body In Patient

Narrative

Description of Event or Problem

PROVIDER WAS PERFORMING A NEPHROLITHOTOMY PROCEDURE AND ATTEMPTED TO ACCESS THE KIDNEY WITH A CHIBA NEEDLE. THEY INSERTED AN ANGLED SENSOR THROUGH THE CHIBA NEEDLE AND IT "STRIPPED" INSIDE THE PATIENT. THEY NOTED THAT IT WAS STRIPPED ON IMAGING. THE WIRE WAS RETRIEVED BUT IT APPEARS THAT A PIECE BROKE OFF INSIDE THE PATIENT AND UNRETRIEVABLE. THE VENDOR REP SHARED THAT ULTRASOUND ENERGY CAN DAMAGE THE WIRE COATING IF THE END OF THE LITHOTRIPTER PROBE PRESSES DIRECTLY ON IT. THIS CAN CAUSE IT TO SPLINTER AND APPEAR TO UNRAVEL. THE PROCEDURE TEAM HAD OPENED THREE WIRES (DIFFERENT LOT NUMBERS) AND CAN'T BE CERTAIN WHICH LOT THIS CAME FROM. PT: 2687. DEVICE: 1261. REF: MW5189417.