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

Model Number M00535900

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The physician is: (b)(6).(b)(4).The returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken and kinked in the handle section.The working length was twisted and kinked and its distal tip was also torn.These findings were consistent to the findings when the device was observed under magnification.A functional evaluation was not performed due to the device condition.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken and kinked in the handle section.These conditions could have been caused due to application of additional force to the device while it is activated during the process or when the device is not in an appropriate position and it is activated.The working length was also twisted and kinked which could have been caused by multiple attempts to rotate the device or during introduction of the device into the scope.Additionally, the working length was torn which could have been caused due to resistance at the cutting wire causing the catheter to tear and displacing the cutting wire notch from its position.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.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 an ultratome xl was intended to be used in the duodenal papilla in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation outside the patient, the physician noticed that the device was twisted as the direction of the cutting wire was incorrect.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 was broken.

• 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: 12480839
• MDR Text Key: 271677352
• Report Number: 3005099803-2021-04810
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2021

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: 06/29/2022
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0025651441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• 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: 58 YR
• Patient Weight: 60