STONETOME
Report
- Report Number
- 3005099803-2025-02034
- Event Type
- Malfunction
- Date Received
- May 14, 2025
- Date of Event
- April 15, 2025
- Report Date
- June 17, 2025
- 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
G4: THE REMAINING PREMARKET/510(K) NUMBER IS K946358; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CUTTING WIRE BROKEN. H11: (INVESTIGATION RESULT): THE RETURNED STONETOME WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE CUTTING WIRE WAS BLACKENED, KINKED, AND BROKEN FROM THE PROXIMAL PIERCE HOLE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE REPORTED EVENT OF CUTTING WIRE BREAK WAS CONFIRMED. UPON ANALYSIS, IT WAS FOUND THAT THE CUTTING WIRE WAS BLACKENED, KINKED, AND BROKEN FROM THE PROXIMAL PIERCE HOLE. BASED ON THE CONDITION OF THE DEVICE, THE WIRE BREAK COULD HAVE BEEN GENERATED IF THERE WAS CONTACT BETWEEN THE DEVICE AND THE SCOPE DURING ENERGIZATION OR IF THE GENERATOR EXCEEDED THE MAXIMUM OF VOLTAGE DURING THE PROCEDURE. ALSO, ENERGIZING THE DEVICE PRIOR TO PERFORMING SPHINCTEROTOMY CAN COMPROMISE THE CUTTING WIRE INTEGRITY AND CAUSE A PREMATURE CUTTING WIRE FATIGUE. ONCE THE CUTTING WIRE BREAKS, ANY ATTEMPT TO REMOVE THE DEVICE FROM THE SCOPE CAN LEAD TO THE BROKEN SECTION HITTING THE WORKING CHANNEL OF THE SCOPE. THIS CAN KINK THE CUTTING WIRE. IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
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 BROKEN.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC BILIARY SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC BILIARY SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE STONETOME BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1090088 | STONETOME | DISLODGER, STONE, BILIARY | LQR | BOSTON SCIENTIFIC CORPORATION | M00535110 | 0035384534 | 08714729146599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |