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

Model Number	M00573060
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on an unknown date.During the procedure, the cutting wire broke.A photo was provided from the customer showing that the cutting wire was intact and the wire anchor was dislodged.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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 wire/anchor dislodged or dislocated.Block h11: investigation results the jagtome rx 44 device was not returned for analysis as it was reported to be lost; therefore, a technical analysis could not be performed.However, a media analysis was performed on the photo provided by the complainant.The photo revealed that the wire anchor was dislodged.No other problems with the device were noted.According to the media analysis performed, it was found that the wire anchor dislodged, this condition could have been caused by submitting the cutting wire to tension during the handle actuation, in addition with the possibility of the device being energized during the handle actuation.Also, bowing the device without being completely out of the scope can displace or dislodge the cutting wire anchor from its position.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of wire/anchor dislodged or dislocated was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• Brand Name: JAGTOME 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: 25038800
• Report Number: 3005099803-2026-01598
• Device Sequence Number: 10370329
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: (01)08714729776673(17)290115(10)38368534
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/29/2026

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: M00573060
• Device Catalogue Number: M00573060
• Device Lot Number: 0038368534
• 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: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 01/16/2026
• 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