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

Model Number	M00584260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution rx was used during a sphincterotomy procedure performed on (b)(6) 2022.During the procedure, after a sphincterotomy, while in use, the cutting wire of the jagtome revolution rx broke.There were no reported patient complications as a result of this event.No further information has been obtained.
Additional Manufacturer Narrative
Medwatch number is mw5113567.(b)(4).

• 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: 16064681
• Report Number: 3005099803-2022-07770
• Device Sequence Number: 2009314
• Product Code: KNS
• UDI-Device Identifier: 08714729953258
• UDI-Public: 08714729953258
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2022

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 Expiration Date: 09/29/2025
• Device Model Number: M00584260
• Device Catalogue Number: 8426
• Device Lot Number: 0030254723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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