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

Model Number	M00583190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome dreamwire 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During procedure, at the moment of the passage of electric current for the opening of the papilla the cutting blade 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 broken.
Event or Problem Description
It was reported to boston scientific corporation that a truetome dreamwire 44 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During procedure, at the moment of the passage of electric current for the opening of the papilla the cutting blade 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 broken.Block h11: investigation results: the device was not returned for analysis despite good faith efforts.Media analysis was performed where it was possible to observe the capital equipment with its parameter settings; however, the photo of the device itself was not presented to determine the problem of the device; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of wire break could not be confirmed.The device was not returned for analysis despite good faith efforts.The customer provided a picture where it was possible to observe the capital equipment with its parameter settings, however, the photo of the device itself was not presented to determine the problem of the device.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of wire break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.

• Brand Name: TRUETOME DREAMWIRE 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 ; 9145716918
• MDR Report Key: 23708881
• Report Number: 3005099803-2025-06435
• Device Sequence Number: 10628891
• Product Code: KNS
• UDI-Device Identifier: 08714729858737
• UDI-Public: (01)08714729858737(17)270320(10)36111255
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/30/2026

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: M00583190
• Device Catalogue Number: M00583190
• Device Lot Number: 0036111255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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 Sex: Unknown