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

Model Number	M00573100
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the jagtome rx 39 would not bow.The handle looked fine and multiple tactics were tried to get it bowed, and then it was noticed that the cutting wire was already broken, that's why it did not bow.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: note: it was reported that the device energized prior to bowing; however, per the instructions for use (ifu), "precaution: the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity." additionally, the device energized when not in contact with tissue; however, per the ifu, "precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.".
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.

• 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: 18757556
• Report Number: 3005099803-2024-00672
• Device Sequence Number: 3838220
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: 08/17/2026
• Device Model Number: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 0032248594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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