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

Model Number	M00583050
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a0406 captures the reportable event of cutting wire kink.
Event or Problem Description
It was reported to boston scientific corporation that an hydratome rx was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, the cutting wire was broken upon bowing of the tome in preparing for sphincterotomy.It was reported that no part of the cutting wire detached and fell into the patient.A photo was provided of the device outside the patient and shows the cutting wire was broken and kinked.The procedure was completed with another hydratome rx.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 break.Imdrf device code a0406 captures the reportable event of cutting wire kink.Block h11: investigation results: the hydratome rx device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the wire was blackened, broken and kinked after use.No other problems with the device were noted.According to the media analysis performed, it was possible to observe that the cutting wire was kinked and broken from the proximal pierce hole, it was most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Wire broken could have been generated if there was contact between the device and the scope during energization or if the device exceeds the maximum of voltage during procedure as per precautions of the device states, also energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, also it can cause a premature cutting wire fatigue, leading to break it.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire as observed in the product analysis.Based on all gathered information, the probable cause selected is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an hydratome rx was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis performed on (b)(6) 2025.During the procedure, the cutting wire was broken upon bowing of the tome in preparing for sphincterotomy.It was reported that no part of the cutting wire detached and fell into the patient.A photo was provided of the device outside the patient and shows the cutting wire was broken and kinked.The procedure was completed with another hydratome rx.There were no patient complications reported as a result of this event.

• Brand Name: HYDRATOME 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: 23493852
• Report Number: 3005099803-2025-05892
• Device Sequence Number: 13003170
• Product Code: KNS
• UDI-Device Identifier: 08714729755203
• UDI-Public: (01)08714729755203(17)280629(10)36871099
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/04/2025

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: M00583050
• Device Catalogue Number: M00583050
• Device Lot Number: 0036871099
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 06/30/2025
• 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