MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOM REVOLUTION PRO RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584470
Medical Device Problem Codes	Failure to Align (2522); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution pro rx 39 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, it was noted that the shielding on the cut wire was separated from the cut wire after cannulation of the common bile duct.Reportedly, the device bowed correctly however it would not release the bow.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photo of the complaint device outside the patient was provided by the customer and showed the cutting wire insulation was damage.

• Brand Name: JAGTOM REVOLUTION PRO RX 39
• 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: 20683818
• Report Number: 3005099803-2024-05587
• Device Sequence Number: 7196969
• Product Code: KNS
• UDI-Device Identifier: 00191506039318
• UDI-Public: 00191506039318
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K232162
• 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
• Report Date (Section B): 11/14/2024

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: M00584470
• Device Catalogue Number: M00584470
• Device Lot Number: 0034627838
• 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: 10/18/2024
• Initial Report FDA Received Date: 11/14/2024
• Date Device Manufactured: 08/13/2024
• 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: Unknown