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

Model Number	M00584170
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a wire break.
Event or Problem Description
Note: this report pertains to one of the two truetome 44 used during the same procedure.It was reported to boston scientific corporation that a truetome 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2026.During the procedure, blade portion of the truetome broke off and the shaft may have been significantly twisted.A second truetome 44 was used; however, the same problem occurred.It was reported that the procedure was completed using this device.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of the two truetome 44 used during the same procedure.It was reported to boston scientific corporation that a truetome 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2026.During the procedure, blade portion of the truetome broke off and the shaft may have been significantly twisted.A second truetome 44 was used; however, the same problem occurred.It was reported that the procedure was completed using this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a wire break.Block h11: the returned truetome 44 was analyzed, and a visual evaluation noted that the cutting wire was blackened, kinked and broken from the proximal pierced hole.Also, the working length was twisted.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was kinked and broken.The physical damage to the device could have been generated if there was contact between the device and the scope during energization or if the device exceeded the maximum voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can bent the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Additionally, it was found the working length was twisted.Working length twisted could be caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.Based on all gathered information, the most probable root cause is adverse event related to procedure.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of wire break and wire kinked were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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: 24345454
• Report Number: 3005099803-2026-00609
• Device Sequence Number: 10004910
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: (01)08714729827634(17)270204(10)35777214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: M00584170
• Device Catalogue Number: M00584170
• Device Lot Number: 0035777214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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