MalfunctionFFL
ZERO TIP
Received Jul 16, 2026 · Event occurred Jun 18, 2026
Report 2124215-2026-38227 · MDR key 25841647
Device
Generic name
Dislodger, Stone, Basket, Ureteral, Metal
Manufacturer
Boston Scientific CorporationModel number
M0063901050Catalog number
M0063901050
Lot number
0037477555
Product problems
- Detachment of Device or Device Component
Patient
53 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A ZERO-TIP BASKET IS USED IN A PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT AFTER ENTERING THE PATIENT'S BODY, THE BASKET COULD NOT GRAB THE STONE AND FOUND THAT THE WHOLE BASKET FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BASKET DETACHMENT.