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

Model Number	M00573100
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	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was attempted to be used in the common bile duct (cbd) and pancreatic duct (pd) during an endoscopic retrograde cholangiopancreatography (ercp) with mac sedation for pancreatic mass and biliary obstruction procedure performed on (b)(6) 2025.During the procedure, the common bile duct and pancreatic duct were cannulated with guidewire, cholangiogram performed and then sphincterotomy performed.During sphincterotomy, it was noted that one end of the cutting wire on the sphincterotome had become detached.The tome was immediately removed through the scope.At this point, the doctor was satisfied with the extent of the sphincterotomy, so no new tome was required.It was reported that no part of the cutting wire detached and fell into the patient.Endoscopic retrograde cholangiopancreatography (ercp) continued with additional cholangiogram, balloon sweeps and stent placement.Bleeding from mouth noted during the procedure.Anesthesia evaluated and determined the patient to be stable with no ventilation impairment, so ercp was completed.Post ercp an esophagogastroduodenoscopy (egd) scope was reintroduced to evaluate source of blood.Potential source seen in stomach with no active bleeding, so no further interventions was performed.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.Overnight the patient was admitted to medical intensive care unit (micu) due to a gastrointestinal (gi) bleed.The bleeding was noted to be in the stomach when rescoped.No bleeding was seen at ampulla.It was reported that there were no intervention performed to treat the bleeding and the jagtome rx 39 was unrelated to the caused of the bleeding.Note: it was indicated 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.
Additional Manufacturer Narrative
Block h2 (additional information and correction): block b5 (describe event or problem) has been updated.Block b7 (other relevant history) has been corrected.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was attempted to be used in the common bile duct (cbd) and pancreatic duct (pd) during an endoscopic retrograde cholangiopancreatography (ercp) with mac sedation for pancreatic mass and biliary obstruction procedure performed on (b)(6) 2025.During the procedure, the common bile duct and pancreatic duct were cannulated with guidewire, cholangiogram performed and then sphincterotomy performed.During sphincterotomy, it was noted that one end of the cutting wire on the sphincterotome had become detached.The tome was immediately removed through the scope.At this point, the doctor was satisfied with the extent of the sphincterotomy, so no new tome was required.It was reported that no part of the cutting wire detached and fell into the patient.Endoscopic retrograde cholangiopancreatography (ercp) continued with additional cholangiogram, balloon sweeps and stent placement.Bleeding from mouth noted during the procedure.Anesthesia evaluated and determined the patient to be stable with no ventilation impairment, so ercp was completed.Post ercp an esophagogastroduodenoscopy (egd) scope was reintroduced to evaluate source of blood.Potential source seen in stomach with no active bleeding, so no further interventions was performed.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.Overnight the patient was admitted to medical intensive care unit (micu) due to a gastrointestinal (gi) bleed.The bleeding was noted to be in the stomach when rescoped.No bleeding was seen at ampulla.It was reported that there were no intervention performed to treat the bleeding and the jagtome rx 39 was unrelated to the caused of the bleeding.Note: it was indicated 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 information received on january 01, 2026.It was reported that the patient was being treated for pancreatic lesion and bile duct stricture.

• Brand Name: JAGTOME 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: 23889193
• Report Number: 3005099803-2025-06887
• Device Sequence Number: 20026502
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: (01)08714729776536(17)280817(10)37234684
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: M00573100
• Device Catalogue Number: M00573100
• Device Lot Number: 0037234684
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 08/18/2025
• 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