MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Jagtome RX 44; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00573060
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was attempted to be used in the common duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones in the common duct performed on (b)(6) 2026.During the procedure.The cutting wire came out of the packaging twisted, and when turned the sphincterotome to perform sphincterotomy, the cutting wire snapped.It was reported that no part of the cutting wire was detached and fell into the patient.A second jagtome rx 44 was attempted to be used; however, the cutting wire was completely twisted.They did not introduce it in the patient and discarded it immediately.The procedure was completed with a third jagtome rx 44.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.Note: it was reported that the cutting wire came out of the packaging twisted; however, per the instructions for use (ifu), precaution: kinks in the catheter will hinder injection capability.Do not use the sphincterotome if any defect is found during inspection.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was attempted to be used in the common duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones in the common duct performed on (b)(6) 2026.During the procedure.The cutting wire came out of the packaging twisted, and when turned the sphincterotome to perform sphincterotomy, the cutting wire snapped.It was reported that no part of the cutting wire was detached and fell into the patient.A second jagtome rx 44 was attempted to be used; however, the cutting wire was completely twisted.They did not introduce it in the patient and discarded it immediately.The procedure was completed with a third jagtome rx 44.There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.Note: it was reported that the cutting wire came out of the packaging twisted; however, per the instructions for use (ifu), precaution: kinks in the catheter will hinder injection capability.Do not use the sphincterotome if any defect is found during inspection.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results the device was not returned for analysis as the device was disposed; therefore, a technical analysis could not be performed.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 break 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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; +1(914)571-6918
• MDR Report Key: 25661255
• Report Number: 3005099803-2026-02610
• Device Sequence Number: 18753958
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: (01)08714729776673(17)290412(10)39066044
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

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: 0039066044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: 07/13/2026; Not provided
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/07/2026; 09/04/2026
• Date Device Manufactured: 04/13/2026
• 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