STONETOME
Report
- Report Number
- 3005099803-2025-03839
- Event Type
- Malfunction
- Date Received
- August 11, 2025
- Date of Event
- July 17, 2025
- Report Date
- September 26, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LQR
- PMA / PMN Number
- K191789
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 BREAK.
BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CUTTING WIRE BREAK. BLOCK H11: INVESTIGATION RESULTS THE RETURNED STONETOME WAS ANALYZED, AND A VISUAL INSPECTION FOUND THAT THE CUTTING WIRE WAS BLACKENED, KINKED AND BROKEN FROM THE PROXIMAL PIERCE HOLE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF CUTTING WIRE BREAK WAS CONFIRMED. THE RESULTS OF THE ANALYSIS PERFORMED ON THE RETURNED DEVICE FOUND THAT THE CUTTING WIRE WAS KINKED AND BROKEN FROM THE PROXIMAL PIERCE HOLE. 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. THE BREAK IN THE CUTTING WIRE COULD HAVE BEEN GENERATED IF THERE WAS CONTACT BETWEEN THE DEVICE AND THE SCOPE DURING ENERGIZATION OR IF THE DEVICE EXCEEDED THE MAXIMUM OF VOLTAGE DURING PROCEDURE. ALSO, ENERGIZING THE DEVICE PRIOR TO PERFORMING SPHINCTEROTOMY CAN COMPROMISE THE CUTTING WIRES INTEGRITY, CAUSING PREMATURE CUTTING WIRE FATIGUE. ONCE THE CUTTING WIRE BREAKS, ANY ATTEMPT TO REMOVE THE DEVICE FROM THE SCOPE CAN BEND THE CUTTING WIRE AS OBSERVED IN THE PRODUCT ANALYSIS. THE INVESTIGATION FINDINGS AND ALL INFORMATION AVAILABLE CONCLUDES THE MOST PROBABLE ROOT CAUSE IS AN ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONETOME WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A BILE DUCT STONE REMOVAL PROCEDURE TO TREAT A BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE CONDUCTING ENDOSCOPIC SPHINCTEROTOMY (EST), THE WIRE SUDDENLY BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. 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 ATTEMPTED TO BE USED IN THE BILE DUCT DURING A BILE DUCT STONE REMOVAL PROCEDURE TO TREAT A BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE CONDUCTING ENDOSCOPIC SPHINCTEROTOMY (EST), THE WIRE SUDDENLY BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONETOME. 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 |
|---|---|---|---|---|---|---|---|
| 2034840 | STONETOME | DISLODGER, STONE, BILIARY | LQR | BOSTON SCIENTIFIC CORPORATION | M00535110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |