MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY

Model Number	M00535110
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: STONETOME
• Common Device Name: DISLODGER, STONE, BILIARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23926903
• Report Number: 3005099803-2025-06936
• Device Sequence Number: 13095980
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: (01)08714729146599(17)270623(10)36816693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00535110
• Device Catalogue Number: M00535110
• Device Lot Number: 0036816693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown