SENSOR
Received Jun 15, 2026 · Event occurred Jun 2, 2026
Report MW5189416 · MDR key 25501212
Device
Generic name
Stylet For Catheter, Gastro-urology
Manufacturer
Boston Scientific CorporationLot 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.