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

Model Number M00535900

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the ultratome xl broke.The device was removed from the duodenoscope, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h2 (additional information): block b has been updated based on the additional information received on november 27, 2023.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the wire was broken and kinked at the handle section.The working length was kinked at the hypotube section, and the working length was also twisted, consistent with the findings when the device was observed under magnification.Additionally, it was torn at the distal pierce hole, and the anchor was dislodged.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken and kinked at the handle section, and the working length was kinked at the hypotube section, which could have been due to handling and manipulation of the device during its use can lead to kink/bending of the working length at the proximal section.It is possible that the kink at the proximal section could have caused some internal tension forces between the cannula and the wire during the handle actuation, this condition could affect the overall performance of the device and lead to breaking it.It was also found that the working length was twisted, which could be caused after multiple attempts to rotate the device or during the introduction of the device into the scope.Also, the anchor was dislodged, and the working length was torn at the distal pierce hole section, which could have been caused by submitting the cutting wire to tension during the handle actuation, in addition with the possibility of the device being energized during the handle actuation, the analyzed problem could happen.Also bowing the device without being completely out of the scope can lead to tear it and displacing the cutting wire anchor from its position.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 an ultratome xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the ultratome xl broke.The device was removed from the duodenoscope, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on november 27, 2023: it was reported that the cutting wire broke inside the duodenoscope, and it was removed through the duodenoscope.Additionally, no part of the cutting wire detached and fell into the patient.

• 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: 18223424
• MDR Text Key: 329347866
• Report Number: 3005099803-2023-06385
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0030825063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 59 KG