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

Model Number	M00583040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the hepatopancreatic biliary during an endoscopic retrograde cholangiopancreatography (ercp) performed on may/june.The specific date is unknown.After the procedure, patient coming back in with delayed bleeding from the sphincterotomy due to the incorrect erbe settings.The bleeding was treated with endoscopic hemostasis.It was reported that the procedure was completed with the original device at the time of event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the event date provided (may/june).The exact date is unknown.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage/bleeding.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.

• 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: 23327672
• Report Number: 3005099803-2025-05404
• Device Sequence Number: 9910439
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: (01)08714729755197
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00583040
• Device Catalogue Number: M00583040
• 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: 09/25/2025
• Initial Report FDA Received Date: 10/17/2025
• 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