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

Model Number	M00584470
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution pro rx 39 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, while performing sphincterotomy and bow feature of the device was engaged, the cutting wire broke.It was reported that no part of the cutting wire detached and fell into the patient.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 h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf device code a040601 captures the reportable event of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution pro rx 39 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, while performing sphincterotomy and bow feature of the device was engaged, the cutting wire broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event additional information received december 31, 2025.It was reported that the device was energized when not in contact with tissue.However, per the instructions for use (ifu), precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.
Additional Manufacturer Narrative
Block h2 (additional information) block b5, and block h6 have been updated based on the additional information received on december 31, 2025.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf device code a040601 captures the reportable event of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution pro rx 39 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, while performing sphincterotomy and bow feature of the device was engaged, the cutting wire broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event ***additional information received december 31, 2025*** it was reported that the device was energized when not in contact with tissue.However, per the instructions for use (ifu), precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf device code a040601 captures the reportable event of cutting wire kinked.Block h11: media inspection of the photo provided by the customer found that the cutting wire of the jagtome revolution pro rx 39 was broken and kinked.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of cutting wire break and cutting wire kinked were confirmed.The photo analysis revealed that the cutting wire of the jagtome revolution pro rx 39 was broken and kinked.The device was not returned for investigation because it was reported to be disposed.The device was used in a manner inconsistent with a written instruction in the ifu.According to the ifu states: precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and or patient injury; however, the complainant reported that the device was energized when not in contact with tissue.Based on all gathered information, the most probable root cause is failure to follow instructions.A labeling review was performed and, from the information available, this device was not used per the instructions for use (ifu) / product label.

• Brand Name: JAGTOME REVOLUTION PRO 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23931466
• Report Number: 3005099803-2025-06951
• Device Sequence Number: 5611565
• Product Code: KNS
• UDI-Device Identifier: 00191506039318
• UDI-Public: (01)00191506039318(17)280513(10)36517324
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup
• Report Date (Section B): 02/15/2026

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: M00584470
• Device Catalogue Number: M00584470
• Device Lot Number: 0036517324
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 01/22/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/15/2026
• Date Device Manufactured: 05/14/2025
• 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