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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as initial reporter facility name exceeded the character limit for the designated field.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 truetome jag 44 was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cbd stones performed on (b)(6) 2026.After unpacking, it was found that the cutting head deviated from the cutting wire, and the inner core of the handle was fractured.The procedure was completed with another of the same device.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
Block e1: the initial reporter facility name is (b)(6); reported here as initial reporter facility name exceeded the character limit for the designated field.Block h2 (correction): block e1 initial reporter address 1, initial reporter city, and initial reporter zip/post code have been updated based on information received on february 10, 2026.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 truetome jag 44 was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cbd stones performed on (b)(6) 2026.After unpacking, it was found that the cutting head deviated from the cutting wire, and the inner core of the handle was fractured.The procedure was completed with another of the same device.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.
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 (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cbd stones performed on (b)(6), 2026.After unpacking, it was found that the cutting head deviated from the cutting wire, and the inner core of the handle was fractured.The procedure was completed with another of the same device.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
Block e1: the initial reporter facility name is (b)(6) hospital,; reported here as initial reporter facility name exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: the returned truetome jag 44 was analyzed, visual and microscopic inspection found that the working length was twisted at distal section.The catheter and the wire were incorrectly oriented.Additionally, it was found that the cutting wire was not crimped to the connector joint strength at handle section, also, was bent.The cutting wire wasn't broken.The guidewire was found in good condition.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire break was not confirmed.According to the product analysis performed on the device, it was found that the working length was twisted at distal section.The catheter and the wire were incorrectly oriented.Additionally, it was found that the cutting wire was not crimped to the connector joint strength at handle section.The cutting wire maintains longitudinal tension along the working length and transmits control from the handle to the distal tip.If the cutting wire is not properly crimped or secured at the handle, a loss of tension may occur, creating slack within the system and reducing shaft stability.This condition may lead to deformation such as distal twisting, loss of orientation, and reduced device controllability during use.Therefore, improper crimping of the cutting wire at the handle is considered a plausible contributing factor to the reported event.Also, the cutting wire was observed bent, since the cutting wire was not crimped, any attempt to actuate the handle can bend it.An investigation to address this problem is in progress.Based on all gathered information and the analysis performed, the most probable cause of this complaint is manufacturing deficiency.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: 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: 24317094
• Report Number: 3005099803-2026-00563
• Device Sequence Number: 4942395
• Product Code: KNS
• UDI-Device Identifier: 08714729858645
• UDI-Public: (01)08714729858645(17)270816(10)37226125
• 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,Followup
• Report Date (Section B): 04/24/2026

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: M00583100
• Device Catalogue Number: M00583100
• Device Lot Number: 0037226125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 04/01/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/02/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2025
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG