MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

Model Number M00535920

Device Problems Break (1069); Failure to Fold (1255); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultratome xl was attempted to be used during an endoscopic dilatation of the esophagus procedure performed on (b)(6) 2023.During the procedure, the physician attempted to insert the device but experienced too much tension.The physician tried to remove the tension from the handle but was not successful.The device was removed, and the procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.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.Note: the instructions for use (ifu) indicate that this tome device is indicated for use in the selective cannulation of the common bile ducts (cbd) and the transendoscopic sphincterotomy of the papilla of vater and/or the sphincter of oddi.The sphincterotome can also be used to inject contrast medium.However, the customer reported that the device was used in an esophageal dilation procedure.This event has been deemed a reportable event based on the investigation finding of broken cutting wire.Please refer to block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation results of cutting wire broken.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire at the handle section was broken and kinked.Additionally, the working length was kinked in two sections, at the distal tip and distal section.Due to the physical condition of the returned device, functional testing could not be performed.No other problems with the device were noted.Analysis of the returned device revealed that the cutting wire was broken and kinked at the handle section.The working length was also kinked in two sections, at the distal tip and the distal section.These physical conditions could have been generated by handling and manipulation of the device during the procedure.The kinks in the working length could have caused some internal tension forces between the cannula and the wire during the handle actuation and caused the wire to break in the handle section.Based on all gathered information, the most probable root cause is adverse event related to the procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• 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: 18923715
• MDR Text Key: 337899616
• Report Number: 3005099803-2024-00930
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K930022
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0031508370
• 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: 04/27/2023
• 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