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

Model Number	M00584470
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by a boston scientific corporation (bsc) sales representative.The healthcare facility is: (b)(6).Phone number: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome revolution pro rx 39 was being prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed on (b)(6) 2024.During preparation, upon opening the package, it was observed that the cutting wire of the tome was broken before being used.A photo of the device inside the pouch was provided by the customer and showed that the cutting wire was broken.The procedure was completed with another jagtome revolution pro rx 39.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by a boston scientific corporation (bsc) sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results.The jagtome revolution pro rx 39 device was not returned; however, a media analysis was performed based on the photo provided by the complainant where was possible to observe the device in its opened and labeled pouch with the cutting wire kinked and broken.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.According to the media analysis performed, it was possible to observe the device in its opened and labeled pouch with the cutting wire kinked and broken, however, the most probable cause of the reported the reported event cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.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 pro rx 39 was being prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed on (b)(6) 2024.During preparation, upon opening the package, it was observed that the cutting wire of the tome was broken before being used.A photo of the device inside the pouch was provided by the customer and showed that the cutting wire was broken.The procedure was completed with another jagtome revolution pro rx 39.There were no patient complications reported as a result of this event.

• Brand Name: JAGTOME 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: 21123717
• Report Number: 3005099803-2024-06903
• Device Sequence Number: 15319347
• Product Code: KNS
• UDI-Device Identifier: 00191506039318
• UDI-Public: 00191506039318
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: M00584470
• Device Catalogue Number: M00584470
• Device Lot Number: 0034725387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 08/27/2024
• 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