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

Model Number M00535900

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The returned ultratome xl was analyzed, and a visual examination noted that the wire anchor was dislodged from the distal pierce hole and the working length was torn.The device was torn 4mm from the distal pierce hole to the tip and 12mm from the proximal pierce hole to proximal working length.Additionally, it was noted that the device returned with the pig tail mandrel inside the device.A functional evaluation could not be performed due to the condition of the device.No other issues with the device were noted.The reported event of wire kinked was not confirmed; however, the investigation found the wire anchor dislodged and the working length torn.Based on the condition of the device, the observed damage may have been caused by actuation of the handle in the coiled position or by manipulation during preparation.Based on review and analysis of all available information, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device has no influence on the event.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 directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultratome xl device was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the cutting wire was kinked.The procedure was completed with another ultratome xl 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.The event has been deemed a reportable event based on the investigation finding of anchor wire dislodged.

• 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: 10195894
• MDR Text Key: 197176828
• Report Number: 3005099803-2020-02446
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

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: 07/14/2021
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0024109464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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