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 Fold (1255); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6)2026.During the procedure, the tech mentioned that they were having a hard time bowing the device fully, and that the handle felt like it was sticking.After sphincterotomy was performed and the device was unbowed, it was observed that one side of the cutting wire became dislodged and was sticking out.The procedure was completed with the original device.There was no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of cutting wire anchor dislodged.

• 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 ; +1(914)571-6918
• MDR Report Key: 50803739
• Report Number: 3005099803-2026-03832
• Device Sequence Number: 8643755
• Product Code: KNS
• UDI-Device Identifier: 08714729778264
• UDI-Public: (01)08714729778264(17)280219(10)35893525
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: M00584040
• Device Catalogue Number: M00584040
• Device Lot Number: 0035893525
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 02/19/2025
• 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