MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584190
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: 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 39 was being prepared for used in the papilla during a procedure to treat common bile duct stone to be performed on (b)(6) 2025.During preparation, the cutting wire was bent.The procedure was completed with another truetome 39.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.Block h11: investigation results the returned truetome 44 was analyzed, and a visual inspection found that the cutting wire was kinked.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.This problem could be caused by the used technique for the device manipulation, during its unpacking or during mandrel removal.The investigation findings and all information available concludes the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 39 was being prepared for used in the papilla during a procedure to treat common bile duct stone to be performed on (b)(6) 2025.During preparation, the cutting wire was bent.The procedure was completed with another truetome 39.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.

• Brand Name: TRUETOME 39
• 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: 24025547
• Report Number: 3005099803-2026-00141
• Device Sequence Number: 8952967
• Product Code: KNS
• UDI-Device Identifier: 08714729827658
• UDI-Public: (01)08714729827658(17)270502(10)36430269
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: M00584190
• Device Catalogue Number: M00584190
• Device Lot Number: 0036430269
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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 Age: 67 YR
• Patient Sex: Female