MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573040
Medical Device Problem Codes	Break (1069); Failure to Conduct (1114); Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned jagtome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, kinked and blackened.The device was observed under magnification and the cut of the cutting wire was not smooth, indicating it was not a mechanical cut.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken.Additionally, the cutting wire was kinked and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if there was contact between the device and the scope during energization or if the device exceeded the maximum rating of voltage during procedure.Also, kinking the cutting wire as a result or interaction with the scope and/or additional devices can contribute to a break in the cutting wire.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During procedure, the jagtome rx 44 could not be energized to perform sphincterotomy.The device was rotated eleven times counter clockwise and was set back to neutral orientation; however, still they could not energize the device.They also even tried to bow and reconnect the device but nothing happened.It was reported that the middle of the cutting wire blackened.The procedure was completed another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.

• Brand Name: JAGTOME RX 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12092667
• Report Number: 3005099803-2021-03155
• Device Sequence Number: 4218003
• Product Code: KNS
• UDI-Device Identifier: 08714729776659
• UDI-Public: 08714729776659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 03/29/2024
• Device Model Number: M00573040
• Device Catalogue Number: 7304
• Device Lot Number: 0027060970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1