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

Model Number	M00584170
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was prepared to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cholangiocarcinoma performed on (b)(6) 2026.During the preparation outside the patient, it was reported that the guidewire came out at the middle of the truetome and not though the distal tip.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of device cutting wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Imdrf device code a040601 captures the reportable investigation result of cutting wire kinked.Block h11: (investigation result) the returned truetome 44 was analyzed, and a visual evaluation noted that the cutting wire was kinked and working length was twisted.Wire insertion test was performed, and the guidewire could advance through the entire length without any problems and did come out from the tip.No other problems with the device were noted.After analysis of the returned device, it was determined that the cutting wire was kinked.The problem could have been caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.The twisted working length could be caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.Based on all gathered information, the most probable root cause is adverse event related to procedure.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 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: 24899604
• Report Number: 3005099803-2026-01392
• Device Sequence Number: 8858724
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: (01)08714729827634(17)270926(10)37558635
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: M00584170
• Device Catalogue Number: M00584170
• Device Lot Number: 0037558635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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