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

Model Number	M00584240
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a jagtome revolution rx was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the tech strips the wire to the physician, the coating of the guidewire peeled.The cutting wire also broke inside the duct.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with a non-bsc guidewire and a different sphincterotome.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken and kinked.Additionally, the ptfe coating of the guidewire was also peeled.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf device code a0406 captures the reportable event of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a jagtome revolution rx was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the tech strips the wire to the physician the coating of the guidewire peeled.The cutting wire also broke inside the duct.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with a non-bsc guidewire and a different sphincterotome.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken and kinked.Additionally, the ptfe coating of the guidewire was also peeled.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: (investigation results) the device has not been received for analysis as it was reported to be disposed.A technical analysis could not be performed.Media inspection of the photo provided by the customer found it was possible to observe the cutting wire blackened, kinked and broken and the ptfe coating of the guidewire peeled.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of wire break was confirmed.The wire break could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can kink the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Additionally, the ptfe peeled could have been caused due to attempts to advance through a difficult anatomy, also hitting the tip against a hard surface (scope) can damage the coating of the guidewire.Based on all gathered information, the most probable root cause is adverse event related to procedure.

• Brand Name: JAGTOME REVOLUTION RX
• 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: 22639486
• Report Number: 3005099803-2025-03528
• Device Sequence Number: 9695190
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: (01)08714729953234(17)280516(10)36545276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: M00584240
• Device Catalogue Number: M00584240
• Device Lot Number: 0036545276
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 05/17/2025
• 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
• Patient Sex: Unknown