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

Model Number	M00584190
Medical Device Problem Codes	Entrapment of Device (1212); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one truetome 39 and one jagwire device used in the same patient and procedure.It was reported to boston scientific corporation that a truetome 39 was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stricture performed on (b)(6) 2025.During the procedure, the device was loaded over a 0.035 jagwire, and cannulated successfully, but could not be exchanged as the wire was stuck in the device.It was then realized that this wire was not compatible with the tome.Both tome and wire were removed from patient, and a non-boston scientific device were attempted to be used, but unable to recannulate the bile duct.The procedure was not completed and was canceled after the patient had been sedated with general anesthesia.There were no patient complications reported as a result of this event.Note: the complainant reported that the device was loaded over a 0.035 jagwire.However, according to the directions for use (dfu), the truetome 39 sphincterotome is capable of accepting a 0.025 in (0.64 mm) guidewire.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.

• Brand Name: TRUETOME 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22548345
• Report Number: 3005099803-2025-03326
• Device Sequence Number: 8727112
• Product Code: KNS
• UDI-Device Identifier: 08714729827658
• UDI-Public: (01)08714729827658(17)270130(10)35746401
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 07/18/2025

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: M00584190
• Device Catalogue Number: M00584190
• Device Lot Number: 0035746401
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 01/30/2025
• 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