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

Model Number	M00584120
Medical Device Problem Codes	Failure to Align (2522); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 the reportable investigation result of cutting wire failure to release bow (unbow).Imdrf device code a040601captures the reportable investigation result of cutting wire kinked.Block h11: investigation results the returned truetome 39 was analyzed, a visual inspection found that the working length was bent and twisted, the cutting wire was popping out and bent.Functional test was performed; the device was actuated and was able to bow but unable to completely unbow.No other problems with the device were noted.The results of the analysis performed on the returned device found the cutting wire was kinked and the device was unable to release the bow (unbow).Also, it was found that the working length was twisted and kinked, this could be caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.These problems could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.Additionally, the wire was unable to unbow and popping out; this event was escalated with operations team, and it was determined that the wire was overly tensioned.The product investigation findings and all information available concludes the most probable root cause is manufacturing deficiency.An investigation to address this problem is in progress.
Event or Problem Description
Boston scientific received a truetome 39 which was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.This event has been deemed reportable based on the investigation results of wire failure to release bow and wire kinked.Please see block h11 for full investigation details.

• 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: 24234746
• Report Number: 3005099803-2026-00389
• Device Sequence Number: 18387684
• Product Code: KNS
• UDI-Device Identifier: 08714729827771
• UDI-Public: (01)08714729827771(17)261008(10)35019070
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: M00584120
• Device Catalogue Number: M00584120
• Device Lot Number: 0035019070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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