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); Failure to Conduct (1114); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution rx was used in the bile duct and ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the device was successfully cannulated and was advanced to make a sphincterotomy.It was noticed that the patient had a non-boston scientific pancreatic stent sticking out of the duct.The device was temporarily energized and then it could not be energized for about 1 to 2 seconds.An attempt was made to reconnect the device and swapped the generator, and then it was noticed that the wire was broken.It was reported that no part of the cutting wire detached and fell into the patient.In the physician's assessment, since he noticed the pancreatic stent marker (made of a radiopaque metal) was right in the area of where the cutting wire was placed, he thought that the metallic marker interfered with energizing the device and caused it to snap.The tome was pressed up against the pancreatic stent while it was being energized with minimal bowing.The procedure was completed with another jagtome revolution rx.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h11: investigation results: the returned jagtome revolution rx was analyzed, and a visual and microscopic inspection found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.Functional testing could not be performed due to the device condition.The cutting wire was observed blackened, indicating that the device was energized and able to conduct.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was confirmed.The analysis of the returned device found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.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.The wire could break if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire integrity, causing premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire as observed in the product analysis.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution rx was used in the bile duct and ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the device was successfully cannulated and was advanced to make a sphincterotomy.It was noticed that the patient had a non-boston scientific pancreatic stent sticking out of the duct.The device was temporarily energized and then it could not be energized for about 1 to 2 seconds.An attempt was made to reconnect the device and swapped the generator, and then it was noticed that the wire was broken.It was reported that no part of the cutting wire detached and fell into the patient.In the physician's assessment, since he noticed the pancreatic stent marker (made of a radiopaque metal) was right in the area of where the cutting wire was placed, he thought that the metallic marker interfered with energizing the device and caused it to snap.The tome was pressed up against the pancreatic stent while it was being energized with minimal bowing.The procedure was completed with another jagtome revolution rx.There were no patient complications reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19339106
• Report Number: 3005099803-2024-02201
• Device Sequence Number: 20600499
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: 08714729953234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/24/2024

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: 8424
• Device Lot Number: 0033617118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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 Sex: Female