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

Model Number	M00584040
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device was inserted through the duodenoscope.The tip of the tome cannulated the ampulla and the wire was fed into the duct.When the device was advanced into the ampulla to create a space between the tome and the scope for sphincterotomy, the technician bowed the tome, and the cutting wire started to go under tome and tip of the tome made the form of a z.This created unnecessary force on the ampulla in a more vascular area on the ampulla.The device was removed and manually straightened and bowed outside the scope with no problem.When placed back through the scope and out of the working channel, the same problem occurred where the tome made the form of a z.The procedure was completed with another of the same device.It was reported that there was a patient bleed that was addressed with a mechanical tamponade with balloon.Additionally, it was reported that the patient has fully recovered.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of cutting wire kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: (investigation result).The returned dreamtome rx 44 was analyzed, and a visual evaluation noted that the working length was twisted at distal section, the cutting wire was kinked.The guidewire was not returned.Functional evaluation noted that the wire bowed correctly (in plane).Additionally, media inspection shows that it was possible to observe the device with the cutting wire kinked, the other pictures showed the device bowed and unbowed, however, no reference point to determine if the device bowed out of plane.No other problems with the device were noted.The reported event of cutting wire kinked was confirmed.Upon analysis, it was found that the working length was twisted at distal section, the cutting wire was kinked.Based on the condition of the device, the wire kinked could have been generated by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device was inserted through the duodenoscope.The tip of the tome cannulated the ampulla and the wire was fed into the duct.When the device was advanced into the ampulla to create a space between the tome and the scope for sphincterotomy, the technician bowed the tome, and the cutting wire started to go under tome and tip of the tome made the form of a z.This created unnecessary force on the ampulla in a more vascular area on the ampulla.The device was removed and manually straightened and bowed outside the scope with no problem.When placed back through the scope and out of the working channel, the same problem occurred where the tome made the form of a z.The procedure was completed with another of the same device.It was reported that there was a patient bleed that was addressed with a mechanical tamponade with balloon.Additionally, it was reported that the patient has fully recovered.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23092520
• Report Number: 3005099803-2025-04658
• Device Sequence Number: 15873293
• Product Code: KNS
• UDI-Device Identifier: 08714729778264
• UDI-Public: (01)08714729778264(17)280615(10)36772087
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/15/2025

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: M00584040
• Device Catalogue Number: M00584040
• Device Lot Number: 0036772087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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