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

Model Number	M00584050
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.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 dreamtome rx 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary disease performed on (b)(6), 2025.During the procedure, the cutting wire snapped.A photo of the complaint device was provided and showed that the cutting wire was broken and kinked.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another dreamtome rx 44.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary disease performed on (b)(6) 2025.During the procedure, the cutting wire snapped.A photo of the complaint device was provided and showed that the cutting wire was broken and kinked.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another dreamtome rx 44.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 break.Imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: investigation results the dreamtome rx 44 device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the cutting wire was kinked and broken.No other problems with the device were noted.According to the media analysis performed, it was possible to observe that the cutting wire was kinked and broken, however, the most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.

• Brand Name: DREAMTOME RX 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22509613
• Report Number: 3005099803-2025-03279
• Device Sequence Number: 21158087
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280307(10)36023287
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• 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,Followup
• Report Date (Section B): 08/22/2025

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: M00584050
• Device Catalogue Number: M00584050
• Device Lot Number: 0036023287
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 03/08/2025
• 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