MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME PRO RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584380
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an autotome pro rx 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary stones performed on (b)(6) 2025.During the procedure, after the physician successfully cannulated with the autotome and dreamwire.The physician was in a position to perform the sphincterotomy.After the tech bowed the tome and the physician started to make the cut, the cut wire broke at the proximal end (away from the tip of the scope) where it attaches to the scope.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with different device.There were no patient complications reported as a result of this event.Note: the complainant reported that the exposed cutting wire was not fully exited the endoscope when the device was energized; however, according to the instructions for use (ifu), warning: verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.

• Brand Name: AUTOTOME PRO RX 44
• 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: 22318801
• Report Number: 3005099803-2025-02799
• Device Sequence Number: 8924387
• Product Code: KNS
• UDI-Device Identifier: 00191506039226
• UDI-Public: (01)00191506039226(17)280212(10)35846206
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K232162
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: M00584380
• Device Catalogue Number: M00584380
• Device Lot Number: 0035846206
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 02/12/2025
• 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