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

Model Number	M00583140
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones in the common bile duct performed on (b)(6) 2026.During the procedure, the truetome was pushed into the ampulla and upon pulling it out the cut wire came off from the truetome.The procedure was completed with another of the same device.A video was provided by the customer and showed that the wire anchor was dislodged.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event and the patient's condition was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire anchor dislodged.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a wire anchor dislodged.Block h11: investigation results: the truetome jag 44 device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.A media analysis was performed on the video provided by the complainant.The video revealed that the device in patients' anatomy with the wire anchor dislodged.No other problems with the device were noted.According to the media analysis performed, it was found that the wire anchor dislodged, however, there is not enough evidence to determine whether the problem was induced due to the physician's technique during the procedure or was related to a device malfunction.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones in the common bile duct performed on (b)(6) 2026.During the procedure, the truetome was pushed into the ampulla and upon pulling it out the cut wire came off from the truetome.The procedure was completed with another of the same device.A video was provided by the customer and showed that the wire anchor was dislodged.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event and the patient's condition was reported to be fully recovered.

• Brand Name: TRUETOME JAG 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24423813
• Report Number: 3005099803-2026-00691
• Device Sequence Number: 13404259
• Product Code: KNS
• UDI-Device Identifier: 08714729858683
• UDI-Public: (01)08714729858683(17)270602(10)36656914
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K122203
• 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): 03/30/2026

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: M00583140
• Device Catalogue Number: M00583140
• Device Lot Number: 0036656914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 06/02/2025
• 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