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

Model Number	M00583100
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a040601 captures the reportable investigation result of wire kinked.Block h11: (investigation results) the returned truetome jag 44 was analyzed, and a visual evaluation noted that the working length was twisted, and the cutting wire was kinked.The device was returned without a guidewire.No other problems with the device were noted.The product analysis revealed that the cutting wire was kinked.This condition could have occurred due to the device manipulation, possibly during preparation in which an excess of force was applied in order to get the device out of the package or during mandrel removal.The device instructions for use (ifu) indicates that the user should hold the distal tip and pull mandrel out of the sphincterotome (be careful to keep procurved shape of tip) and avoid handle extension/retraction while it is in a coiled position as kinking of the catheter shaft may occur, rendering the device inoperable.These procedural factors could have contributed to the device problem found.Based on all gathered information, the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was used in the porta hepatis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation outside the patient, it was reported that the tip of the tome and the cutting wire were offset, and the attempt to intubate was unsuccessful.The tip of the tome was not in the correct position with the cutting wire; it was in a coiled shape and unable to be rotated.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.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.

• 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: 23752500
• Report Number: 3005099803-2025-06643
• Device Sequence Number: 5904675
• Product Code: KNS
• UDI-Device Identifier: 08714729858645
• UDI-Public: (01)08714729858645(17)270301(10)35968827
• 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
• Report Date (Section B): 12/08/2025

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: 0035968827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 55 KG