STONE CONE
Received Mar 3, 2026 · Event occurred Nov 25, 2025
Report 2124215-2026-11594 · MDR key 24501045
Device
Generic name
Dislodger, Stone, Flexible
Manufacturer
Boston Scientific CorporationModel number
390-320Catalog number
390-320
Lot number
0009145371
Product problems
- Peeled/Delaminated
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IMDRF DEVICE CODE A040506 CAPTURES THE REPORTABLE EVENT OF COIL PEELED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF COIL PEELED WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. A LABELING REVIEW WAS PERFORMED ON THE DEVICE INSTRUCTIONS FOR USE (IFU). IFU STATES: PRIOR TO USE, ENSURE THAT THE COIL IS WORKING PROPERLY BY ADVANCING THE SHEATH OVER THE COIL TO THE POSITIVE STOP AND THEN RETRACTING THE SHEATH TO OPEN THE COIL. THE SHEATH OF THE DEVICE SHOULD BE STRAIGHT DURING TESTING. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. THEREFORE, AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT A STONE CONE WAS USED DURING A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL HAD PEELED OFF AND COULD NOT BE USED. REPORTEDLY, THE ENTIRE BASKET DID NOT DETACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT A STONE CONE WAS USED DURING A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL HAD PEELED OFF AND COULD NOT BE USED. REPORTEDLY, THE ENTIRE BASKET DID NOT DETACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A040506 CAPTURES THE REPORTABLE EVENT OF COIL PEELED.