STONETOME
Report
- Report Number
- 3005099803-2025-06936
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Date of Event
- December 1, 2025
- Report Date
- February 12, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LQR
- UDI-DI
- 08714729146599
- PMA / PMN Number
- K191789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K946358; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H2: BLOCK G2 REPORT SOURCE HAS BEEN CORRECTED. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CUTTING WIRE BREAK. BLOCK H11: PRODUCT INVESTIGATION. THE RETURNED STONETOME WAS ANALYZED, A VISUAL INSPECTION FOUND THAT THE WORKING LENGTH WAS TWISTED AT DISTAL SECTION, THE CUTTING WIRE WASN'T BROKEN. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF WIRE BREAK WAS NOT CONFIRMED. ACCORDING TO THE PRODUCT ANALYSIS PERFORMED ON THE DEVICE, THE WORKING LENGTH WAS TWISTED; THIS PROBLEM COULD BE CAUSED BY AFTER MULTIPLE ATTEMPTS TO ROTATE THE DEVICE OR DURING THE INTRODUCTION OF THE DEVICE INTO THE SCOPE. BASED ON ALL GATHERED INFORMATION AND THE ANALYSIS PERFORMED, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS ADVERSE EVENT RELATED TO PROCEDURE.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K946358; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CUTTING WIRE BREAK.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, UPON ENERGIZATION, THE BLADE DETACHED, CAUSING THE PRODUCT TO BECOME UNUSABLE. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED AND FELL INTO THE PATIENT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, UPON ENERGIZATION, THE BLADE DETACHED, CAUSING THE PRODUCT TO BECOME UNUSABLE. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED AND FELL INTO THE PATIENT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1887692 | STONETOME | DISLODGER, STONE, BILIARY | LQR | BOSTON SCIENTIFIC CORPORATION | M00535110 | 0036816693 | 08714729146599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |