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

Model Number	M00584120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 39 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the cutting wire broke when the nurse tried to pull the handle to retract the cut wire.The procedure was completed with another truetome 39.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b5 has been updated based on the additional information received on march 12, 2025.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 39 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the cutting wire broke when the nurse tried to pull the handle to retract the cut wire.The procedure was completed with another truetome 39.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information was received on march 12, 2025: it was reported that no part of the cutting wire detached and fell into the patient.The anatomy location involved was ampulla.

• 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: 21587942
• Report Number: 3005099803-2025-01006
• Device Sequence Number: 8868618
• Product Code: KNS
• UDI-Device Identifier: 08714729827771
• UDI-Public: (01)08714729827771(17)250815(10)32229277
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 08/15/2025
• Device Model Number: M00584120
• Device Catalogue Number: M00584120
• Device Lot Number: 0032229277
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/01/2025
• Date Device Manufactured: 08/16/2023
• 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