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

Model Number	M00584240
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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) 2026.During the procedure, wire broke off catheter while they were about to use cautery.The cutting wire was intact, but the wire anchor dislodged from the catheter.It was reported that no part of the device was detached and fell inside the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire/anchor dislodged.
Event or Problem Description
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) 2026.During the procedure, wire broke off catheter while they were about to use cautery.The cutting wire was intact, but the wire anchor dislodged from the catheter.It was reported that no part of the device was detached and fell inside the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire/anchor dislodged.Block h11: investigation closed the returned jagtome revolution rx was analyzed, and visual inspection found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.The wire anchor was not dislodged.The device returned without a guidewire.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire/anchor dislodged or dislocated was not confirmed.According to the product analysis performed on the device, the cutting wire was kinked and broken from the proximal pierce hole, it is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Wire broken could have been generated if there was contact between the device and the scope during energization or if the device exceeds the maximum of voltage during procedure as per precautions of the device states, also energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, also it can cause a premature cutting wire fatigue, leading to break it.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire.Based on all gathered information and the analysis performed, the most probable cause of this complaint is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• 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: 24471424
• Report Number: 3005099803-2026-00767
• Device Sequence Number: 13165704
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: (01)08714729953234(17)281105(10)37899175
• 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): 04/15/2026

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: M00584240
• Device Catalogue Number: M00584240
• Device Lot Number: 0037899175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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