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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stone performed on (b)(6) 2025.During the procedure, when the electrotomy was performed after the power supply was connected, the cutting wire of the tome was fractured.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another truetome jag 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of cutting wire break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results: the returned truetome jag 44 was analyzed, and a visual and microscopic inspection found that the cutting wire was blackened, broken and detached, also, the device had contrast residues.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 cutting wire break was confirmed.The results of the analysis performed on the returned device found that the cutting wire was broken and detached.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 wires 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 detach it.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stone performed on (b)(6) 2025.During the procedure, when the electrotomy was performed after the power supply was connected, the cutting wire of the tome was fractured.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another truetome jag 44.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 23228359
• Report Number: 3005099803-2025-05038
• Device Sequence Number: 18563476
• Product Code: KNS
• UDI-Device Identifier: 08714729858645
• UDI-Public: (01)08714729858645(17)260925(10)34928882
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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 Expiration Date: 09/25/2026
• Device Model Number: M00583100
• Device Catalogue Number: M00583100
• Device Lot Number: 0034928882
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 63 KG