MalfunctionFGO
Stone Cone
Received Apr 22, 2026 · Event occurred Mar 26, 2026
Report 2124215-2026-21791 · MDR key 24956121
Device
Generic name
Dislodger, Stone, Flexible
Manufacturer
Boston Scientific CorporationModel number
M0063903200Catalog number
390-320
Lot number
0009301194
Product problems
- Break
- Nonstandard Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A STONE CONE COIL RETRIEVAL WAS SET TO BE USED DURING A TRANSURETHRAL URETEROLITHOTRIPSY PROCEDURE. PRIOR TO PROCEDURE, WHILE OUTSIDE THE PATIENT'S BODY THERE WAS DIFFICULTY IN RETRACTING THE COIL; HOWEVER, AFTER REPEATED PULLING ATTEMPTS THE WIRE GOT DAMAGED AT THE SHEATH SECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF PULL WIRE BREAK.