MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME? RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome rx 39 was attempted to be used in the common bile duct during a procedure performed on an unknown date.During the procedure, the autotome was inserted through the scope and advanced to the papilla in a normal fashion.The autotome was engaged into the ampulla, then the wire snapped inside the common bile duct.The auto tome was then removed.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 h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Additional Manufacturer Narrative
Block a1, a2, a3a, a3b, b3 and b5 have been updated based on additional information received july 3, 2025.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 an autotome rx 39 was attempted to be used in the common bile duct during a procedure performed on an unknown date.During the procedure, the autotome was inserted through the scope and advanced to the papilla in a normal fashion.The autotome was engaged into the ampulla, then the wire snapped inside the common bile duct.The auto tome was then removed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Additional information was received on july 3, 2025: it was reported that the event date was on may 28, 2025.

• Brand Name: AUTOTOME? RX 39
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 22365876
• Report Number: 3005099803-2025-02870
• Device Sequence Number: 20905206
• Product Code: KNS
• UDI-Device Identifier: 08714729444770
• UDI-Public: (01)08714729444770(17)280116(10)35645605
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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 Model Number: M00545200
• Device Catalogue Number: M00545200
• Device Lot Number: 0035645605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/28/2025
• Date Device Manufactured: 01/16/2025
• 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 Age: 69 YR
• Patient Sex: Male