MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584150
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an truetome 49 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure for bile duct dilatation performed on (b)(6) 2025.During preparation outside the patient for a common bile duct dilation procedure, the truetome 39 sphincterotome was unpacked and prepared for guide wire pre-installation.Upon inspection, the tip of the sphincterotome was found to be bent.Despite attempts, intubation was unsuccessful using this device.The procedure was subsequently completed successfully using another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results: the cutting wire kinked.Please refer to block h11 for full investigation details.
Additional Manufacturer Narrative
H6: imdrf device code a0406 captures the reportable investigation result of cutting wire kinked.H11: (investigation results): the returned truetome 49 was analyzed, and a visual and microscopic evaluation noted that the working length was bent and twisted at distal section.Additionally, the cutting wire was also bent.No other problems with the device were noted.The product analysis revealed that the cutting wire was bent.Also, the working length was bent and twisted at the distal section.These conditions could have been generated due to the device manipulation, possibly during preparation an excess force was applied in order to get the device out of the package or during preparation.Per the ifu, precaution: avoid handle extension/retraction while it is in a coiled position.Kinking of the catheter shaft may occur, rendering the device inoperable.Based on all gathered information, the most probable root cause is unintended use error caused or contributed to event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: TRUETOME 49
• 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: 23985499
• Report Number: 3005099803-2026-00072
• Device Sequence Number: 19991168
• Product Code: KNS
• UDI-Device Identifier: 08714729827610
• UDI-Public: (01)08714729827610(17)270118(10)35659920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: M00584150
• Device Catalogue Number: M00584150
• Device Lot Number: 0035659920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2025
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 50 KG