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

Model Number M00584170

Device Problems Crack (1135); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned truetome 44 was analyzed, and a visual evaluation noted that the cutting wire was dislodged.The device was observed under magnification and it was observed that the tip was cracked, the working length was torn from this distal pierced hole and was kinked.Additionally, the cutting wire was blackened.No other problems with the device were noted.The product analysis revealed that the cutting wire anchor was dislodged.This condition could have been generated if the catheter was submitted to tension forces during handle actuation or if the device was bowed without being completely out of the scope.This can cause the working length to tear and displacing the cutting wire notch from its position.Also, the tip was found cracked and this was likely due to interaction with a hard surface.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the bile duct during an endoscopic retrograde cholangiography procedure performed on (b)(6) 2021.During the procedure, it was noticed that the plastic catheter tip was damaged.The procedure was completed another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results: the cutting wire anchor was dislodged.

• 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: 13536444
• MDR Text Key: 288374287
• Report Number: 3005099803-2022-00642
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: 08714729827634
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 0026909849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 73 KG