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 Fold (1255); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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 for the treatment of choledocholithiasis performed on (b)(6) 2025.During the procedure, the cutting wire could not be fully tensioned, which prevented a complete papillotomy from being performed.Since further tensioning was not possible, the device was removed for external inspection.Upon examination, it was found that the cutting wire did not extend across the full length of the tip.The cutting wire ended at the brown marking instead of the blue tip.The procedure was completed with another dreamtome rx 44.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a wire kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.Block h11: investigation results.The returned dreamtome rx 44 was analyzed, and a visual and microscopic inspection found that the cutting wire was kinked, also, the distal pierced hole (tome's extrusion) was torn; therefore, this last condition displaced the cutting wire anchor from its original position (the wire anchor is still within the catheter), due to this condition the device was not able to bow during functional test.No other problems with the device were noted.The results of the analysis performed on the returned device found that the cutting wire was kinked.This problem could be caused by operational factors, such as manipulating the device through difficult anatomy, the used technique for the device manipulation or by the interaction between the device and the scope (hitting against a hard surface).The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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: 22515597
• Report Number: 3005099803-2025-03361
• Device Sequence Number: 15468421
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280217(10)35861036
• 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
• Report Date (Section B): 07/15/2025

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: M00584050
• Device Catalogue Number: M00584050
• Device Lot Number: 0035861036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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