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

Model Number	M00584240
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation results of cutting wire kinked.Block h11: (investigation result) the returned jagtome revolution rx was analyzed, and a visual evaluation noted that the working length was twisted at distal section, the cutting wire was kinked at the handle section and the excess wire was popping out from the working length.The wire was not oriented between 10:30-1:00 (47-116 degrees) and the device bowed out of plane during functional testing.No other problems with the device were noted.The product analysis revealed that the working length was twisted at the distal section and the cutting wire was kinked at the handle section with the excess wire popping out from the working length.The twisted working length could have been generated after multiple attempts to rotate handle of the device during the introduction of the device into the scope.Additionally, the cutting wire was kinked at the handle section and the excess wire was popping out from the working length.This caused the device to bowed out of plane and could kink the wire at the handle section.Based on all gathered information, the most probable root cause is manufacturing deficiency.An investigation to address this problem is in progress.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution rx was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device was inserted and bowed correctly but the cut wire orientation out of the scope was out of position.An attempt was made to manipulate the tome by rotating the handle without success.The procedure was completed with a second jagtome revolution rx.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of device cutting wire kinked.Please see block h11 for full investigation details.

• Brand Name: JAGTOME REVOLUTION RX
• 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: 22813056
• Report Number: 3005099803-2025-03940
• Device Sequence Number: 21008453
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: 08714729953234
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: M00584240
• Device Catalogue Number: M00584240
• Device Lot Number: 0035161689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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