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); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was prepared to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During preparation outside the patient, the device was unpacked and the guide wire was being pre-installed.It was then observed that the tip of the tome was bent to the right and could not be rotated using the handle to adjust to the normal insertion angle.As a result, the catheter could not be inserted successfully during the procedure.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 results: the cutting wire kinked.Please refer to block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: investigation results the returned truetome 49 was analyzed, and a visual inspection found that the cutting wire was kinked.Additionally, the working length was also bent.No other problems with the device were noted.The product analysis of the returned device revealed that the cutting wire was kinked and the working length bent.The cutting wire kinked resulted in orientation problem.These conditions could have been generated by operational factors, the used technique for the device manipulation during unpacking or during mandrel removal.Once the cutting wire is kinked, this could result in difficulty advancing or inserting the device through a scope or device.Based on all gathered information, the most probable root cause of this complaint is unintended use error caused or contributed to event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review was completed and confirmed that the event of wire kinked was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 24634516
• Report Number: 3005099803-2026-01006
• Device Sequence Number: 21006956
• Product Code: KNS
• UDI-Device Identifier: 08714729827610
• UDI-Public: (01)08714729827610(17)270508(10)36476134
• 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): 03/18/2026

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: M00584150
• Device Catalogue Number: M00584150
• Device Lot Number: 0036476134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 50 KG