MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONETOME; DISLODGER, STONE, BILIARY

Model Number M00535110

Device Problems Break (1069); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1 (initial reporter city, state): (b)(6) block h6: imdrf device code a0401 captures the reportable investigation results of cutting wire broken.Block h10: the returned stonetome was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and kinked from the proximal pierce hole, which are consistent with the findings when the device was observed under magnification.Additionally, the handle was in good condition and the proximal pierce hole was torn.Functionally, the continuity test cannot be performed due to the device condition (the cutting wire broken from the proximal section in an angle of 90 degree).No other problems with the device were noted.The product analysis revealed that the cutting wire was broken, blackened, and kinked from the proximal pierce hole.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.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.Additionally, the working length was torn at the proximal pierce hole, which could have been caused by submitting the cutting wire to tension during the handle actuation and with the possibility of the device being energized during the handle actuation, also bowing the device without being completely out of the scope can lead to tear it.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 stonetome was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the stonetome could not be energized at first and then it was noticed that the cutting wire was only oriented in a three-way direction.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken from the proximal pierce hole.Please refer to block h10 for full investigation details.

• Brand Name: STONETOME
• Type of Device: DISLODGER, STONE, BILIARY
• 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: 18733420
• MDR Text Key: 336744659
• Report Number: 3005099803-2024-00563
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946358
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00535110
• Device Catalogue Number: 3511
• Device Lot Number: 0032154212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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