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

Model Number	M00584180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct (cbd) stone performed on (b)(6) 2026.During the procedure, the cutting wire of the truetome broke immediately upon insertion, rendering the device unusable.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported due to this event and the patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h2 (additional information): block e1 initial reporter phone number and email address have been updated based on the additional information received on (b)(6) 2026.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h11: the returned truetome 44 was analyzed, and a visual evaluation found no physical damage to the device.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of wire break was not confirmed.The product analysis revealed that the device did not have any visible damage or evidence of wire break that could have contributed to the reported event.Based on all gathered information, the most probable root cause is device problem excluded.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review was completed and confirmed that the event of wire break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct (cbd) stone performed on (b)(6) 2026.During the procedure, the cutting wire of the truetome broke immediately upon insertion, rendering the device unusable.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported due to this event and the patient's condition at the conclusion of the procedure was reported to be fully recovered.

• Brand Name: TRUETOME 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: 24277972
• Report Number: 3005099803-2026-00490
• Device Sequence Number: 8318900
• Product Code: KNS
• UDI-Device Identifier: 08714729827641
• UDI-Public: (01)08714729827641(17)271003(10)37620121
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/18/2026

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: M00584180
• Device Catalogue Number: M00584180
• Device Lot Number: 0037620121
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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