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

Model Number	M00584240
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged or dislocated.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution rx was used in a procedure performed on (b)(6) 2025.It was reported that the cutting wire of the jagtome revolution rx would not raise up and appeared to be loose in one end.No further information has been obtained despite good faith efforts.The reported event may suggest that the wire/anchor was dislodged or dislocated.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution rx was used in a procedure performed on (b)(6) 2025.It was reported that the cutting wire of the jagtome revolution rx would not raise up and appeared to be loose in one end.No further information has been obtained despite good faith efforts.The reported event may suggest that the wire/anchor was dislodged or dislocated.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged or dislocated.Block h11: (investigation result).The returned jagtome revolution rx was analyzed, and a visual and microscopic evaluation noted that the distal pierced hole (tomes extrusion) was torn; the cutting wire anchor was displaced from its original position, but the wire anchor is still within the catheter and was not dislodged.No other problems with the device were noted.The reported event of cutting wire anchor dislodged or dislocated was not confirmed.Upon analysis, it was found that the distal pierced hole was torn (working length torn).The torn distal pierced hole could have been generated by submitting the catheter to tension forces during the handle actuation and bowing the device without being completely out of the scope that can lead to tear and displace the cutting wire anchor from its position.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: 21588492
• Report Number: 3005099803-2025-00948
• Device Sequence Number: 12951123
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: (01)08714729953234(17)271113(10)35279014
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 0035279014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White