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); Failure to Conduct (1114); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a040601 captures the reportable event of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cholangitis performed on (b)(6) 2026.During the procedure, the physician instructed her assistant to tighten the device to facilitate further incision.After pressing on the cautery, no current was generated.Prior to continuing the procedure, the physician inspected the device and observed that the metal tip of the sphincterotome was fractured.A photo of the complaint device was provided and showed that the cutting wire was broken and kinked.It was reported that no part of the cutting wire detached and fell into the patient.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 okay.

• 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 ; +1(914)571-6918
• MDR Report Key: 25788844
• Report Number: 3005099803-2026-02766
• Device Sequence Number: 5953220
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: (01)08714729827634
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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
• 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: 06/16/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/10/2026
• 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: 37 YR
• Patient Sex: Male