MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584150
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the facility name exceeded character limit for 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 49 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to performed on (b)(6) 2025.During the procedure, the device was advanced, and the tip of the cutting wire and the bow were bent.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 the facility name exceeded character limit for designated field.Block h2: block e1 has been updated based on additional information received on october 19, 2025.Correction: block h11 (additional mfr narrative).Block h6: imdrf device code a0406 captures the reportable event of cutting wire kink.Block h11: (investigation results) the returned truetome 49 was analyzed, and a visual evaluation noted that the cutting wire and the working length were kinked.Also, it was found that the distal pierced hole (tome's extrusion) was torn; therefore, this last condition displaced the cutting wire anchor from its original position (the wire anchor is still within the catheter).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 the cutting wire were kinked.This problem could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.Also, it was found that distal pierced hole was torn (working length torn) and this condition caused the wire anchor to displace.The working length torn at the pierce hole could have been caused by submitting the catheter to tension forces during the handle actuation, also bowing the device without being completely out of the scope can lead to tear it and displace the cutting wire anchor from its position.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 49 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to performed on (b)(6) 2025.During the procedure, the device was advanced, and the tip of the cutting wire and the bow were bent.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.

• Brand Name: TRUETOME 49
• 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: 23260945
• Report Number: 3005099803-2025-05218
• Device Sequence Number: 4916822
• Product Code: KNS
• UDI-Device Identifier: 08714729827610
• UDI-Public: (01)08714729827610(17)261107(10)35239343
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: M00584150
• Device Catalogue Number: M00584150
• Device Lot Number: 0035239343
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/19/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG