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

Model Number	M00584180
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 44 was attempted to be used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stenosis in the bile duct performed on (b)(6) 2025.During the procedure, when tightening the sheath wire to cut the papilla, the cutting wire broke.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results.The returned truetome 44 was analyzed, and a visual and microscopic inspection found that cutting wire was blackened, kinked and broken from the proximal pierce hole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was confirmed.The results of the analysis performed on the returned device found that the cutting wire was kinked and broken from the proximal pierce hole.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instruction for use (ifu)/product label.
Event or Problem Description
Procedure summary: it was reported to boston scientific corporation that a truetome 44 was attempted to be used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stenosis in the bile duct performed on (b)(6) 2025.Event summary: during the procedure, when tightening the sheath wire to cut the papilla, the cutting wire broke.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.Patient status: there were no patient complications reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22734608
• Report Number: 3005099803-2025-03899
• Device Sequence Number: 7125744
• Product Code: KNS
• UDI-Device Identifier: 08714729827641
• UDI-Public: (01)08714729827641(17)260624(10)34305438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 09/10/2025

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 Expiration Date: 06/24/2026
• Device Model Number: M00584180
• Device Catalogue Number: M00584180
• Device Lot Number: 0034305438
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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 Sex: Unknown