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

Model Number	M00584180
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was used in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary tract stones performed on (b)(6) 2025.During the procedure, a sphincterotomy was performed.The sphincterotome was inserted deep into the papilla of vater.When the wire was bowed by the nurse, the wire broke on the proximal side of the catheter.It was reported that no part of the cutting wire detached and fell into the patient.The doctor concluded that the incision was sufficient and completed the procedure.Photos of the complaint device outside the patient were provided and show the cutting wire is broken and kinked.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 cutting wire break.Imdrf device code a0406 captures the reportable event of cutting wire kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: investigation results the returned truetome 44 was analyzed, and a visual inspection found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.Media analysis was performed based on the photos provided where it was possible to observe the cutting wire was broken and kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break and cutting wire kinked was confirmed.The results of the analysis performed on the returned device found that the cutting wire was kinked and broken from the proximal pierce hole.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.The break in the cutting wire could have been generated if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wires integrity, causing premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can bend the cutting wire as observed in the product analysis.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was used in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary tract stones performed on (b)(6) 2025.During the procedure, a sphincterotomy was performed.The sphincterotome was inserted deep into the papilla of vater.When the wire was bowed by the nurse, the wire broke on the proximal side of the catheter.It was reported that no part of the cutting wire detached and fell into the patient.The doctor concluded that the incision was sufficient and completed the procedure.Photos of the complaint device outside the patient were provided and show the cutting wire is broken and kinked.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter phone and fax numbers) have been corrected.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: investigation results: the returned truetome 44 was analyzed, and a visual inspection found that the cutting wire was blackened, kinked and broken from the proximal pierce hole.Media analysis was performed based on the photos provided where it was possible to observe the cutting wire was broken and kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break and cutting wire kinked was confirmed.The results of the analysis performed on the returned device found that the cutting wire was kinked and broken from the proximal pierce hole.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.The break in the cutting wire could have been generated if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wires integrity, causing premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can bend the cutting wire as observed in the product analysis.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was used in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary tract stones performed on (b)(6) 2025.During the procedure, a sphincterotomy was performed.The sphincterotome was inserted deep into the papilla of vater.When the wire was bowed by the nurse, the wire broke on the proximal side of the catheter.It was reported that no part of the cutting wire detached and fell into the patient.The doctor concluded that the incision was sufficient and completed the procedure.Photos of the complaint device outside the patient were provided and show the cutting wire is broken and kinked.There were no patient complications reported as a result of this event.

• 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: 22337561
• Report Number: 3005099803-2025-02845
• Device Sequence Number: 18391000
• Product Code: KNS
• UDI-Device Identifier: 08714729827641
• UDI-Public: (01)08714729827641(17)260826(10)34717923
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 10/24/2025

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: 08/26/2026
• Device Model Number: M00584180
• Device Catalogue Number: M00584180
• Device Lot Number: 0034717923
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 10/22/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/12/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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 Sex: Unknown