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

Model Number	M00573040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to the first of two jagtome rx 44 devices used during the same procedure.It was reported to boston scientific corporation that a jagtome rx 44 was used in the major duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when they tried to cut the papilla the cutting wire broke.The device was slightly tensed but current was not applied.A second jagtome was used; however, the cutting wire was also broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with third jagtome.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was detached, bent and blackened.Also, the working length was bent at 54cm from guidewire introducer port.Additionally, under magnification inspection the cut surface of the cutting wire was observed to be not smooth.A functional evaluation could not be performed due to the condition of the device.No other issues with the device were noted.The reported event of cutting wire broke was confirmed.Upon analysis, the cutting wire was found detached, bent and blackened.Also, the working length was bent in proximal section.The cutting wire being blackened indicates that the device was energized.The failure found could had been generated if the device was not completely in contact with the tissue during procedure or if voltage exceeded the maximum voltage rating.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 directions for use (dfu) / product label.
Event or Problem Description
Note: this report pertains to the first of two jagtome rx 44 devices used during the same procedure.It was reported to boston scientific corporation that a jagtome rx 44 was used in the major duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on july 30, 2020.According to the complainant, during the procedure, when they tried to cut the papilla the cutting wire broke.The device was slightly tensed but current was not applied.A second jagtome was used; however, the cutting wire was also broke.Reportedly, no part of the device was detached inside the patient.The procedure was completed with third jagtome.There were no patient complications reported as a result of this event.

• 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: 10442352
• Report Number: 3005099803-2020-03498
• Device Sequence Number: 2713880
• Product Code: KNS
• UDI-Device Identifier: 08714729776659
• UDI-Public: 08714729776659
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 04/30/2023
• Device Model Number: M00573040
• Device Catalogue Number: 7304
• Device Lot Number: 0025483878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1