MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was being prepared for use in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on december 7, 2023.During preparation, when the packaging of the device was opened, it was noticed that the plastic catheter was split, and the cutting wire anchor was dislodged.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: imdrf device code a051201 captures the reportable event of wire anchor dislodged.
Additional Manufacturer Narrative
Block h6: imdrf device code a051201 captures the reportable event of wire anchor dislodged.Block h10: the returned jagtome rx 39 was analyzed, and a visual evaluation noted that the device was in good condition.The preloaded guidewire was also returned, and it was noted that the distal tip of the guidewire was popping out of the rapid exchange channel.The device was observed under magnification, and the cutting wire was kinked.Additionally, the distal tip of the guidewire was detached, and the tip of the guidewire (pebax) was physically damaged with what appeared to be tear marks.No other problems with the device were noted.The reported event of wire/anchor dislodged was not confirmed.Upon analysis, it was found that the tip and the anchor of the returned device were in good condition.However, the cutting wire of the device was kinked, the tip (pebax) of the returned guidewire was physically damaged and the distal tip of the guidewire was detached.These device conditions could have occurred during manipulation of the device.Attempts made by the physician to place the tip inside the tome and/or the force applied to the device during preparation/unpacking of the device could have led to the observed damages.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was being prepared for use in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, when the packaging of the device was opened, it was noticed that the plastic catheter was split, and the cutting wire anchor was dislodged.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: JAGTOME RX 39
• 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: 18423624
• Report Number: 3005099803-2023-06875
• Device Sequence Number: 8109201
• Product Code: KNS
• UDI-Device Identifier: 08714729776642
• UDI-Public: 08714729776642
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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 Expiration Date: 06/19/2026
• Device Model Number: M00573080
• Device Catalogue Number: 7308
• Device Lot Number: 0031850777
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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