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); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, when bowing the tome, the wire kinked.A photo of the complaint device was provided where it can be observed that the cutting wire was kinked.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, when bowing the tome, the wire kinked.A photo of the complaint device was provided where it can be observed that the cutting wire was kinked.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: investigation results the truetome 49 device was not returned; however, a media analysis was performed based on the photo provided by the complainant where was possible to observe the cutting wire anchor displaced from its original position (the wire anchor is still within the catheter), this condition is only present when the distal pierced hole (tome's extrusion) is torn as seen in the attached photo, also, the cutting wire was observed kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported events of cutting wire kinked was confirmed.According to the media analysis performed, it was found that the cutting wire was kinked.This problem could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, when bowing the tome, the wire kinked.A photo of the complaint device was provided where it can be observed that the cutting wire was kinked.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: investigation results.The returned truetome 49 was analyzed, and a visual and microscopic inspection found that the distal pierced hole (tome's extrusion) was torn; therefore, this last condition displaced the cutting wire anchor from its original position (the wire anchor is still within the catheter).Media analysis was performed based on the photo provided by the complainant where was possible to observe the device with the cutting wire kinked and displaced from its original position.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire kinked was confirmed.The results of the analysis performed on the returned device found that the cutting wire was kinked and the distal pierced hole was torn (working length torn).The kinked found on the cutting wire could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 23251674
• Report Number: 3005099803-2025-05194
• Device Sequence Number: 10245782
• Product Code: KNS
• UDI-Device Identifier: 08714729827610
• UDI-Public: (01)08714729827610(17)261119(10)35315237
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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,Followup
• Report Date (Section B): 03/17/2026

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: 0035315237
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 03/16/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/14/2025; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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