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

Model Number M00584180

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation results of cutting wire broken.Block h10: the returned truetome 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, kinked, and blackened at 7mm from the proximal pierce hole.Additionally, the working length was kinked and twisted.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken, kinked and blackened from the proximal pierce hole.This condition indicates that the device was energized and actuated, and which could have been generated if there was contact between the device and the scope during energization.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can bend the cutting wire.It was also found that the working length was kinked, which could have been caused by operational factors, such as manipulating the device through difficult anatomy, the technique used during the device manipulation or by the interaction between the device and the scope (hitting against a hard surface).Additionally, the working length was twisted, which could possibly be caused after multiple attempts to rotate handle of the device or during the introduction of the device into the scope.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.Based on all gathered information, the most probable root cause of this complaint is 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 Description

It was reported to boston scientific corporation that a truetome 44 was being prepared to be used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Prior to the procedure, it was reported that the device had an orientation issue.The procedure was completed successfully; however, it was unknown what device was used to complete the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.Please refer to block h10 for full investigation details.

• Brand Name: TRUETOME 44
• Type of Device: 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: 18813369
• MDR Text Key: 336988477
• Report Number: 3005099803-2024-00813
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00584180
• Device Catalogue Number: 8418
• Device Lot Number: 0031485510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1