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	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic sphincterotomy (est) with bile duct stone removal procedure performed on (b)(6) 2024.During the procedure, the cutting wire of the stonetome separated and the procedure could not be continued.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20005007
• Report Number: 3005099803-2024-03992
• Device Sequence Number: 15283673
• Product Code: LQR
• UDI-Device Identifier: 08714729146599
• UDI-Public: 08714729146599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946358
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 04/17/2026
• Device Model Number: M00535110
• Device Catalogue Number: 3511
• Device Lot Number: 0033849806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/20/2024
• Date Device Manufactured: 04/17/2024
• 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