MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00583100
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf device code a0406 captures the reportable event of cutting wire kinked.
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation (bsc) that a truetome jag 44 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, incision of the papilla was performed and the cutting wire on the proximal side of the device broke.A second truetome jag 44 was attempted to be used but, during incision of the papilla, the cutting wire also broke on the proximal side of the device.The procedure was completed with a non-bsc device.It was reported that no part of the cutting wires detached and fell into the patient.Photos of the complaint devices outside the patient were provided by the customer and both showed the cutting wire was broken and kinked.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 a0406 captures the reportable event of cutting wire kinked.Block h11: (investigation result) the returned truetome jag 44 was analyzed, and a visual evaluation noted that the cutting wire was blackened, kinked, and broken at 10 mm from the proximal pierce hole.Additionally, media evaluation noted that the cutting wire was kinked and broken.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was blackened, kinked, and broken at 10mm from the proximal pierce hole.Based on the condition of the device, the wire break could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can kink the cutting wire.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.Based on all gathered information, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation (bsc) that a truetome jag 44 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, incision of the papilla was performed and the cutting wire on the proximal side of the device broke.A second truetome jag 44 was attempted to be used but, during incision of the papilla, the cutting wire also broke on the proximal side of the device.The procedure was completed with a non-bsc device.It was reported that no part of the cutting wires detached and fell into the patient.Photos of the complaint devices outside the patient were provided by the customer and both showed the cutting wire was broken and kinked.There were no patient complications reported as a result of this event.

• Brand Name: TRUETOME JAG 44
• 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: 23146254
• Report Number: 3005099803-2025-04813
• Device Sequence Number: 12972360
• Product Code: KNS
• UDI-Device Identifier: 08714729858645
• UDI-Public: (01)08714729858645(17)270423(10)36354271
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: M00583100
• Device Catalogue Number: M00583100
• Device Lot Number: 0036354271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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