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

Model Number	M00535110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used during a procedure performed on (b)(6) 2025.During the procedure, the blade (cutting wire) was broken.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.
Additional Manufacturer Narrative
Block e1: this event was reported by the boston scientific corporation (bsc) sales representative.The healthcare facility is: (b)(6).Phone number: (b)(6) fax number: (b)(6) 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.
Additional Manufacturer Narrative
Block e1: this event was reported by the boston scientific corporation (bsc) sales representative.The healthcare facility is: (b)(6).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 (additional information): block b5 (describe event or problem) has been updated.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 used during a procedure performed on (b)(6) 2025.During the procedure, the blade (cutting wire) was broken.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.***additional information received on february 21, 2025*** it was reported that no part of the cutting wire detached and fell into the patient.It was reported that the type of procedure performed was endoscopic sphincterotomy (est) and the anatomy location was papilla of vater.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21417344
• Report Number: 3005099803-2025-00458
• Device Sequence Number: 15752850
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: 08714729146599
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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 Expiration Date: 10/03/2026
• Device Model Number: M00535110
• Device Catalogue Number: M00535110
• Device Lot Number: 0034990868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/12/2025
• Date Device Manufactured: 10/03/2024
• 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