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

Model Number	M00584050
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire/anchor dislodged.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cbd stones performed on (b)(6) 2026.During the procedure, when the endoscopist attempted to further bow the instrument to increase the cutting angle and extend the sphincterotomy, the filament wire snapped.It was reported that the cutting wire was intact, but the wire anchor dislodged from the catheter.The procedure was completed with different device.It was reported that no cutting wire was detached into the patient.There were no patient complications as a result of this event and the patient's condition was reported to be 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: 24731880
• Report Number: 3005099803-2026-01141
• Device Sequence Number: 9287051
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280723(10)37050259
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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: M00584050
• Device Catalogue Number: M00584050
• Device Lot Number: 0037050259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 06/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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