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

Model Number	M00584240
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two jagtome revolution rx used in the same procedure.It was reported to boston scientific corporation that a jagtome revolution rx was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, cutting wire bent in half and couldn't be used for sphincterotomy.It was also reported that the wire anchor was dislodged from the catheter.A second jagtome revolution rx was used; however, the same problem occurred.It was reported that no part of the device 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.It was reported that the patient condition was fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a040601 captures the reportable event of cutting wire kinked and cutting wire anchor dislodged or dislocated.
Event or Problem Description
Note: this report pertains to one of two jagtome revolution rx used in the same procedure.It was reported to boston scientific corporation that a jagtome revolution rx was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, cutting wire bent in half and couldn't be used for sphincterotomy.It was also reported that the wire anchor was dislodged from the catheter.A second jagtome revolution rx was used; however, the same problem occurred.It was reported that no part of the device 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.It was reported that the patient condition was fully recovered.Additional information was received on january 26, 2026: it was reported that only one jagtome revolution rx had a wire anchor detached and the procedure was completed with the second of the same device.The anatomy location involved was the duodenum.
Additional Manufacturer Narrative
Block g2: block b5 has been corrected.Block b5 has been updated based on the additional information received on january 26, 2026.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a040601 captures the reportable event of cutting wire kinked and cutting wire anchor dislodged or dislocated.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23959972
• Report Number: 3005099803-2026-00026
• Device Sequence Number: 21200672
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: (01)08714729953234(17)280801(10)37118203
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 02/20/2026

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: M00584240
• Device Catalogue Number: M00584240
• Device Lot Number: 0037118203
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 08/02/2025
• 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