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

Model Number	M00573050
Medical Device Problem Codes	Failure to Fold (1255); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.Block h11: investigation results the returned jagtome rx 44 was analyzed, and a visual inspection found the cutting wire was kinked.The device was inspected under magnification and was observed that the proximal pierced hole (tomes extrusion) was torn, this condition displaced the cutting wire from its original position during actuation.The combination between the kink in the cutting wire and the torn section in the working length resulted in the wire inability to bow.No other problems with the device were noted.The product analysis of the returned device revealed the cutting wire kinked.This condition could be caused by operational factors, the used technique for the device manipulation or by the interaction between the device and a hard surface.The proximal pierced hole was torn (working length torn), due this condition the wire was displaced from its original position.This problem could have been caused by submitting the catheter to tension forces during the handle actuation, also bowing the device without being completely out of the scope.The combined condition limits the overall performance of the device making the device unable to bow.Based on all gathered information, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review was completed and confirmed that the event of wire kinked 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.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat gallstone with cholecystitis performed on (b)(6) 2025.During the procedure, it was reported that the cutting wire could not be pulled up.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results: the cutting wire kinked.Please refer to block h11 for full investigation details.

• 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: 24619678
• Report Number: 3005099803-2026-00992
• Device Sequence Number: 13296382
• Product Code: KNS
• UDI-Device Identifier: 08714729776666
• UDI-Public: (01)08714729776666(17)271124(10)35354929
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: M00573050
• Device Catalogue Number: M00573050
• Device Lot Number: 0035354929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG