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

Model Number	M00584050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gallstones performed on (b)(6) 2025.During the procedure, the cutting wire of the dreamtome rx 44 broke and fell off the patient.It was reported that the detached cutting wire was successfully retrieved using forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf impact code f2301 captures the reportable event of additional device required (forceps) to retrieve the detached wire.
Additional Manufacturer Narrative
Block e1: initial reporter phone number and email address fields have been updated based on the additional information received on august 25, 2025.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf impact code f2301 captures the reportable event of additional device required (forceps) to retrieve the detached wire.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gallstones performed on (b)(6) 2025.During the procedure, the cutting wire of the dreamtome rx 44 broke and fell off the patient.It was reported that the detached cutting wire was successfully retrieved using forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 22438526
• Report Number: 3005099803-2025-03182
• Device Sequence Number: 11563460
• Product Code: KNS
• UDI-Device Identifier: 08714729778271
• UDI-Public: (01)08714729778271(17)280404(10)36237981
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00584050
• Device Catalogue Number: M00584050
• Device Lot Number: 0036237981
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 04/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown