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

Model Number	M00584040
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
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.(biopsy forceps).
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) rendezvous procedure with interventional radiology (ir) performed on (b)(6) 2025.During the procedure, interventional radiology had placed a guidewire percutaneously into the duodenum.The wire straightened out the ampulla so it could be cannulated with the dreamtome rx 44.A sphincterotomy was performed, the cutting wire snapped, and the ir wire was cut clean.It was reported that a portion (.014 inches) of the ir wire detached and fell into the patient but was successfully retrieved using biopsy forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken.Note: the instructions for use (ifu) indicates that the cutting wire should be fully exited the endoscope before applying electrocautery current.However, the customer reported that the cutting wire had not fully exited the endoscope before the device was energized.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) rendezvous procedure with interventional radiology (ir) performed on april 8, 2025.During the procedure, interventional radiology had placed a guidewire percutaneously into the duodenum.The wire straightened out the ampulla so it could be cannulated with the dreamtome rx 44.A sphincterotomy was performed, the cutting wire snapped, and the ir wire was cut clean.It was reported that a portion (.014 inches) of the ir wire detached and fell into the patient but was successfully retrieved using biopsy forceps.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken.Note: the instructions for use (ifu) indicates that the cutting wire should be fully exited the endoscope before applying electrocautery current.However, the customer reported that the cutting wire had not fully exited the endoscope before the device was energized.
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.(biopsy forceps) block h11: investigation results the device did not return for analysis, however, the customer provided pictures where it was possible to observe the opened and labeled pouch, and the device with the cutting wire blackened and broken.With all the available information, boston scientific concludes the reported event of wire break was confirmed.Media evaluation shows the cutting wire was blackened and broken.It was determined that the instructions for use (ifu) of the device weren't follow since the customer reported that the cutting wire had not fully exited the endoscope before the device was energized.This can compromise the cutting wire integrity, also it can cause a premature cutting wire fatigue, leading to break it.Also, additional device (biopsy forceps) was required because of the problem encountered during the procedure.Therefore, the most probable root cause is failure to follow instructions.

• 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: 21930524
• Report Number: 3005099803-2025-01872
• Device Sequence Number: 9086281
• Product Code: KNS
• UDI-Device Identifier: 08714729778264
• UDI-Public: (01)08714729778264(17)280107(10)35576569
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: M00584040
• Device Catalogue Number: M00584040
• Device Lot Number: 0035576569
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 01/07/2025
• 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