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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guidewire bent and broke the last 5cm off.It was reported that no part of the detached guidewire fell into the patient.The procedure was completed using another guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of core wire break.Block h11: investigation results the returned jagtome rx 44 was analyzed, and a visual and microscopic inspection found that the guidewire was kinked at the proximal section and had evidence of a mechanical cut.The working length of the autotome device was twisted.No other problems with the device were noted.The results of the analysis performed on the returned device found that the guidewire was kinked at proximal section and had evidence of a mechanical cut.It is most likely that this physical damage could have occurred due to excess manipulation of the device.It is most likely that as part of the device manipulation during the procedure, an excess of force was applied to the device (such as during the guidewire insertion) through another device or by the interaction with the scope, causing the kink.Therefore, the most probable root cause is an 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.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guidewire bent and broke the last 5cm off.It was reported that no part of the detached guidewire fell into the patient.The procedure was completed using another guidewire.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 attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guidewire bent and broke the last 5cm off.It was reported that no part of the detached guidewire fell into the patient.The procedure was completed using another guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): block h6 (component codes), (evaluation result codes) and block h11 (investigation results) have been updated.Block h6: imdrf device code a0401 captures the reportable event of core wire break.Block h11: investigation results: the returned jagtome rx 44 was analyzed, and a visual and microscopic inspection found that the guidewire was kinked at the proximal section and had evidence of a mechanical cut.The working length of the autotome device was twisted.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of core wire break was confirmed.The results of the analysis performed on the returned device found that the guidewire was kinked at the proximal section and had evidence of a mechanical cut.It is most likely that the kink occurred as part of the device manipulation.During the procedure, if an excess of force was applied to the device, such as during guidewire insertion through another device or by the interaction with the scope, it could cause physical damage to the guidewire.Also, the guidewire returned broken due to a mechanic cut.Additionally, it was found that the working length of the autotome was twisted.This could have been caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.Therefore, the most probable root cause is an 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: 19454056
• Report Number: 3005099803-2024-02518
• Device Sequence Number: 8785586
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 10/03/2024

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: M00573060
• Device Catalogue Number: 7306
• Device Lot Number: 0033201347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 09/09/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 09/06/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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