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

Model Number	M00583080
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 39 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after the device was advanced through the scope and exited the distal end, a significant bend was observed in the cutting wire near its midpoint.This deformation made the device difficult to manipulate.Both the working length and the cutting wire were reported to be bent, causing orientation problem.The procedure was completed with another truetome jag 39.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 have fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.Block h11: investigation results the returned truetome jag 39 was analyzed, and a visual inspection found that the working length and the cutting wire were kinked, due to kinked in the cutting wire, the device was unable to be oriented.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 cutting wire kinked was confirmed.The results of the analysis performed on the returned device found that the working length and cutting wire were 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 by mandrel removal, the damage in the cutting wire makes it unable to be oriented.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.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 39 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after the device was advanced through the scope and exited the distal end, a significant bend was observed in the cutting wire near its midpoint.This deformation made the device difficult to manipulate.Both the working length and the cutting wire were reported to be bent, causing orientation problem.The procedure was completed with another truetome jag 39.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 have fully recovered.

• Brand Name: TRUETOME JAG 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: 23722445
• Report Number: 3005099803-2025-06586
• Device Sequence Number: 12947869
• Product Code: KNS
• UDI-Device Identifier: 08714729858621
• UDI-Public: (01)08714729858621(17)270602(10)36656905
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: M00583080
• Device Catalogue Number: M00583080
• Device Lot Number: 0036656905
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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