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

Model Number	M00584420
Medical Device Problem Codes	Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydratome pro rx 44 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on an unknown date.During the procedure, the tome was leaking.A video clip of the complaint device was provided and showed that the tip of the working length was leaking.Additionally, the cutting wire appeared to be kinked.The procedure was completed with another device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h2 (additional information): block b3 (date of event), block b5 (describe event or problem), block e1 (initial reporter title, name, and phone number), and block e3 (initial reporter occupation) have been updated.Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.Block h11: investigation results the hydra pro rx 44 device was not returned as it was reported to be disposed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the device was leaking liquid from the distal section of the working length, also, was observed that the cutting wire was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire kinked was confirmed.According to the media analysis performed, it was possible to observe the device had a leak in the working length and also had the cutting wire bent.However, the most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome pro rx 44 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on an unknown date.During the procedure, the tome was leaking.A video clip of the complaint device was provided and showed that the tip of the working length was leaking.Additionally, the cutting wire appeared to be kinked.The procedure was completed with another device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.Additional information received on january 12, 2026.It was reported that the event date or procedure date occurred on (b)(6) 2025.It was reported that the anatomy location of the procedure was at the common bile duct and the procedure was completed with another hydratome pro rx 44 device.

• Brand Name: HYDRATOME PRO 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: 23930713
• Report Number: 3005099803-2025-06945
• Device Sequence Number: 18358567
• Product Code: KNS
• UDI-Device Identifier: 00191506039264
• UDI-Public: (01)00191506039264(17)280602(10)36670916
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232162
• 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): 01/30/2026

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: M00584420
• Device Catalogue Number: M00584420
• Device Lot Number: 0036670916
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 06/03/2025
• 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