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

Model Number	M00573060
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the sphincter of oddi biliary tract during a procedure performed on (b)(6) 2024.During the procedure, when the jagtome was removed from the duodenoscope, it was observed that the cutting wire was distended.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 a050701 captures the reportable event of wire was unable to release the bow.
Additional Manufacturer Narrative
Block h6: imdrf device code a050701 captures the reportable event of wire was unable to release the bow.Block h11: investigation results: the returned jagtome rx 44 was analyzed, and a visual inspection found that the cutting wire was popping out at distal section, also, it was observed that the cutting wire was detached from the connector joint strength at handle section, due to this condition the device was not able to bow or unbow during a functional test.The device was checked under x ray, and it was found that cutting wire was not crimped to the connector joint strength at handle section.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of wire failure to release bow (unbow) was confirmed.X ray pictures observed that the cutting wire was not crimped to the connector joint strength at the handle section, due to this condition the autotome device was not able to bow and unbow correctly.It was determined that the cause is related with a manufacturing deficiency.The investigation findings and all information available concludes the most probable root cause is manufacturing deficiency.An investigation to address this problem has been completed.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 used in the sphincter of oddi biliary tract during a procedure performed on (b)(6) 2024.During the procedure, when the jagtome was removed from the duodenoscope, it was observed that the cutting wire was distended.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 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: 19630864
• Report Number: 3005099803-2024-03081
• Device Sequence Number: 15245211
• Product Code: KNS
• UDI-Device Identifier: 08714729776673
• UDI-Public: 08714729776673
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/29/2024

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: 0033479225
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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