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

Model Number	M00573080
Medical Device Problem Codes	Failure to Fold (1255); Failure to Align (2522); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
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 bile ducts during an endoscopic retrograde cholangiopancreatography (ercp) with stone extraction procedure to treat stones in the bile ducts performed on (b)(6) 2025.During preparation, the device was unable to be inserted into the scope.Physician noticed that the tip was bent, unable to bow, and bowing out of plane.The procedure was completed with another of the same device.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 cutting wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: investigation results the returned jagtome rx 39 was analyzed, and a visual inspection found that the working length and the cutting wire were kinked.During functional testing, the device was actuated and the was able to bow and unbow inside and outside of the scope and it bowed in plane.The guidewire was found in good condition.No other problems with the device were noted.The results of the analysis performed on the returned device found that the cutting wire was kinked.This problem could be caused by operational factors, the used technique for the device manipulation, by the interaction between the device and a hard surface or after actuating the device several times.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.

• 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: 23348719
• Report Number: 3005099803-2025-05459
• Device Sequence Number: 21199825
• Product Code: KNS
• UDI-Device Identifier: 08714729776642
• UDI-Public: (01)08714729776642(17)271118(10)35310106
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 10/21/2025

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: M00573080
• Device Catalogue Number: M00573080
• Device Lot Number: 0035310106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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