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

Model Number	M00584150
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation outside the patient, when the device was unpacked, it was found that the cutting wire was bent.The procedure was completed with 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of cutting wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 49 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation outside the patient, when the device was unpacked, it was found that the cutting wire was bent.The procedure was completed with 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: (investigation result) the returned truetome 49 was analyzed, and a visual and microscopic evaluation noted that the working length was torn from the green band to the tip.No other problems with the device were noted.The reported event of cutting wire kinked was not confirmed.Upon analysis, it was found that the working length was torn from the green band to the tip.Based on the condition of the device, the problem on the distal section is typically caused when the user pulls or remove the guidewire through the c-channel, and the technique used during loading or removing the guidewire into the device that could cause the catheter gets torn.Based on all gathered information, the most probable root cause is adverse event related to procedure.

• 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: 22807823
• Report Number: 3005099803-2025-03979
• Device Sequence Number: 8960708
• Product Code: KNS
• UDI-Device Identifier: 08714729827610
• UDI-Public: (01)08714729827610(17)260905(10)34787141
• 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,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 09/05/2026
• Device Model Number: M00584150
• Device Catalogue Number: M00584150
• Device Lot Number: 0034787141
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG