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

Model Number M00584170

Device Problems Failure to Align (2522); Material Deformation (2976)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050701 captures the reportable event of cutting wire unable to release bow (unbow).

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the duodenal papilla ostium during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the handle was actuated to bow the device, it was noticed that the tip of the device bowed and would not release the bow.It was also noticed that the catheter tip was kinked.The procedure was completed with 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.

Manufacturer Narrative

Block h6: imdrf device code a050701 captures the reportable event of cutting wire unable to release bow (unbow).Block h10: the returned truetome 44 was analyzed, and a visual evaluation noted that the working length was twisted at the distal section.A functional evaluation noted that the device was able to bow and returned from the bowed position as intended when the bow test was performed outside and inside the scope.No other problems with the device were noted.The reported event of the wire being unable to release the bow (unbow) was not confirmed.Upon analysis, the device bowed and returned from the bow as intended.It was observed that the working length twisted which could be caused after multiple attempts to rotate the device or during the introduction of the device into the scope.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the duodenal papilla ostium during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the handle was actuated to bow the device, it was noticed that the tip of the device bowed and would not release the bow.It was also noticed that the catheter tip was kinked.The procedure was completed with 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.

• 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: 17139662
• MDR Text Key: 317768852
• Report Number: 3005099803-2023-03224
• 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,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 0029964197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG