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

Model Number	M00583210
Medical Device Problem Codes	Peeled/Delaminated (1454); 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	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: investigation results: the returned truetome dreamwire 44 was analyzed, a visual and microscopic inspection found that the ptfe coating was peeled and also had friction marks.Additionally, the guidewire and the cutting wire were kinked.No other problems with the device were noted.The results of the analysis performed on the returned device found that the cutting wire was kinked.This problem could be caused by operational factors, the used technique for the device manipulation, by the interaction between the device and a hard surface.Also, it was found that the ptfe was peeled, this failure could have been caused due to attempts to advance through a difficult anatomy, insertion/ removal of the guidewire through another device or the interaction with the scope (hitting the device against 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 dreamwire 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, it was noticed that the guide wire was frayed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of cutting wire kinked.Please see block h11 for full investigation details.

• 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: 23660386
• Report Number: 3005099803-2025-06201
• Device Sequence Number: 10124198
• Product Code: KNS
• UDI-Device Identifier: 08714729858751
• UDI-Public: (01)08714729858751
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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 Model Number: M00583210
• Device Catalogue Number: M00583210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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