MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUEtome 44; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00584170
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2026.During the procedure, the cutting wire of the truetome 44 broke.It was reported that no part of the cutting wire detached and fell into the patient.Additionally, it was also reported that the exposed cutting wire did not fully exit the endoscope when the device was energized.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 condition at the conclusion of the procedure was reported to be stable.Note: the complainant reported that the exposed cutting wire did not fully exit the endoscope when the device was energized.; however, according to the instructions for use (ifu), warning: verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.

• 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 ; EI 01752 ; 9145716918
• MDR Report Key: 24778328
• Report Number: 3005099803-2026-01218
• Device Sequence Number: 21313550
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: 0035170799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 145 LB