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

Model Number	M00573060
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was intended to be used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2022.During preparation, the nurse noticed that the device would not completely bow and the cutting wire of the jagtome rx 44 was not attached.It was further clarified that the cutting wire was broken.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: there was a photo provided by the customer showing only the distal end of the device with the cutting wire intact but twisted.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was intended to be used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, the nurse noticed that the device would not completely bow and the cutting wire of the jagtome rx 44 was not attached.It was further clarified that the cutting wire was broken.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: there was a photo provided by the customer showing only the distal end of the device with the cutting wire intact but twisted.
Additional Manufacturer Narrative
Block h6 (device codes): device code a0401 captures the reportable event of cutting wire broken.Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the distal tip was twisted, and the cutting wire was bent and blackened which are consistent with the findings when the device was observed under magnification.There was no evidence of broken wire.Additionally, the working length was torn from the end of the rx channel to the tip and also at the proximal pierced hole.Functionally, when the handle was actuated, it did not bow due to the device condition.Per media inspection on the provided photo, it showed that the distal tip of the device was twisted, and the cutting wire was bent.No other problems with the device were noted.The reported event of cutting wire broken was not confirmed.Upon analysis, there was no evidence of broken wire noted.It was found that the cutting wire was bent and blackened.The cutting wire being blackened indicates that the device was energized.Also, the reported problem working length twisted was confirmed, which could have been caused due to handling and manipulation of the device during procedure, and the interaction with the scope and attempts to rotate the device during procedure to obtain a better position of the device.Once the extrusion was twisted, the problem of working length torn at the proximal pierced hole could have been caused by submitting the catheter to tension forces during the handle actuation.Also, it was found that the working length was torn from the end of the rx channel to the tip.The observed damage on distal section is typically caused when the user pulled/removed the guidewire through the c-channel, also by the technique used during loading/removing the guidewire into the device could have caused the catheter to tear.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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
• 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: 15709916
• Report Number: 3005099803-2022-06259
• Device Sequence Number: 17376571
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 07/22/2025
• Device Model Number: M00573060
• Device Catalogue Number: 7306
• Device Lot Number: 0029820164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2022
• 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