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

Model Number	M00584050
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation result of cutting wire broken.Block h11: investigation result.The returned dreamtome rx 44 was analyzed, and a visual and microscopic examination found that the wire was detached (not crimped) from the connector joint strength joint at handle section, the wire did not have crimp marks, due this condition the wire was unable to bow.The device was disassembled and was found that the aluminum disc was detached and deformed.The guidewire was found in good condition.The customer provided a picture where was possible to observe the handle actuated and the wire unable to bow.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire failure to bow was confirmed.The results of the analysis performed on the returned device found that the wire was detached (not crimped) to the connector joint strength joint at handle section, the wire did not have crimp marks, due this condition the wire was unable to bow.Also, after disassembling, the device was found that the aluminum disc was detached and deformed.The investigation findings and all information available concludes the most probable root cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary stones performed on (b)(6) 2025.During preparation, the nurse noticed the device could not bow.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: wire detached/separated.Please see block h10 for full investigation details.

• 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: 24134233
• Report Number: 3005099803-2026-00269
• Device Sequence Number: 5455538
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280724(10)37057069
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 01/21/2026

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: 0037057069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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