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	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was attempted to be used in the common bile duct (cbd) during an endoscopic sphincterotomy procedure performed on (b)(6) 2024.During the procedure, when energy was applied through the cutting wire, the cutting wire broke after about five seconds.A photo of the device was provided by the customer and showed that the cutting wire was broken and kinked.The procedure was completed with another truetome 44.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21144803
• Report Number: 3005099803-2024-06914
• Device Sequence Number: 21243902
• Product Code: KNS
• UDI-Device Identifier: 08714729827641
• UDI-Public: 08714729827641
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 01/13/2025

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 Model Number: M00584180
• Device Catalogue Number: M00584180
• 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: 12/20/2024
• Initial Report FDA Received Date: 01/13/2025
• 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