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

Model Number	M00584050
Medical Device Problem Codes	Failure to Align (2522); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was attempted to be used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gall stones performed on (b)(6) 2026.During the procedure, the dreamtome rx could not pass the biopsy port of the duodenum scope because the cutting wire of the dreamtome stayed in a bowed position.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.Block h11: investigation results the returned dreamtome rx 44 was analyzed, and visual inspection found that the working length was twisted.Also, the cutting wire was kinked.The device was actuated and was able to bow; however, it could not fully unbow inside or outside the scope due to the kink in the cutting wire.During insertion into the scope, it was difficult to advance the device, as the kink in the cutting wire prevented the tip from returning to a relaxed position.The guidewire was found to be in good condition.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of wire failure to release bow (unbow) was confirmed.The product analysis revealed that the working length was twisted, this damage could be caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.Also, it was found that the cutting wire was kinked, this failure could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.Additionally, the wire was unable to release the bow, the issue appears to be related to a kink in the cutting wire, which affected how the device performed.Because of this, the device could not fully unbow and was difficult to advance through the scope, as the tip was not able to return to its normal position.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of wire failure to release bow (unbow) was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was attempted to be used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gall stones performed on (b)(6) 2026.During the procedure, the dreamtome rx could not pass the biopsy port of the duodenum scope because the cutting wire of the dreamtome stayed in a bowed position.The procedure was completed with another of the same device.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: 24398120
• Report Number: 3005099803-2026-00661
• Device Sequence Number: 12804027
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280825(10)37307544
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 04/02/2026

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: 0037307544
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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