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

Model Number	M00583040
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During the procedure, the cutting wire was intact, but the wire anchor dislodged from the catheter.A photo of the device outside the patient was provided and showed that the cutting wire was intact, but the wire anchor was dislodged from the catheter.The device was removed, and the procedure was completed with another of the same device.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged or dislocated.Block h11: investigation results.The hydratome rx 44 device was not returned for analysis as it was reported to be discarded.Therefore, a technical analysis could not be performed.However, a media analysis was performed on the photo of the device provided by the complainant.The photo revealed that, at the distal tip, the wire anchor was dislodged or dislocated from the distal pierce hole.This problem mode is present when the working length is torn.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire/anchor dislodged or dislocated was confirmed.According to the photo provided by the customer the wire anchor was dislodged or dislocated.The dislodged/dislocated wire anchor could be caused by bowing the device without being completely out of the scope, which can tear the working length and displace or dislodge the cutting wire anchor from its position.Therefore, the most probable cause of this complaint is adverse event related to 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22137606
• Report Number: 3005099803-2025-02386
• Device Sequence Number: 7356491
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: (01)08714729755197(17)280324(10)36145636
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/03/2025

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: M00583040
• Device Catalogue Number: M00583040
• Device Lot Number: 0036145636
• 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: 05/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 03/25/2025
• 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