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

Model Number	M00573040
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
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
It was reported to boston scientific corporation that a jagtome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the tome was passed down the scope it come out with an incorrect orientation.Also, the orientation of the cutting wire was incorrect with respect to the plastic tip.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the tome was passed down the scope it come out with an incorrect orientation.Also, the orientation of the cutting wire was incorrect with respect to the plastic tip.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 3009 captures the reportable event of cutting wire orientation.Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the working length was twisted in the proximal and distal sections.A functional evaluation noted that the initial orientation when the device exited the endoscope was incorrect due to the working length being twisted.No other problems with the device were noted.The reported event was confirmed.Upon analysis, it was found that the working length was twisted causing an incorrect orientation of the device.Based on the condition of the device, the wire orientation problem could have been generated during manipulation of the device or due to the interaction with the endoscope during introduction.Additionally, the working length could have twisted upon multiple attempts to rotate the device.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.

• 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: 10586325
• Report Number: 3005099803-2020-04192
• Device Sequence Number: 13745140
• Product Code: KNS
• UDI-Device Identifier: 08714729776659
• UDI-Public: 08714729776659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 07/07/2023
• Device Model Number: M00573040
• Device Catalogue Number: 7304
• Device Lot Number: 0025683386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1