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

Model Number M00535920

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the papilla during an endoscopic papillotomy (ept) procedure performed on (b)(6) 2022.During the endoscopic sphincterotomy (est) procedure, the physician saw some spark on the cutting wire of the ultratome xl, the wire anchor dislodged and then it just broke.The cutting wire detached inside the patient and then it disappeared.He used the endoscope to check the detached piece; however, he could not find it, so there was no any plan to remove the missing wire.Additionally, the physician was expecting the patient to pass the missing wire.They changed the device and the procedure was completed with 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.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: medical device problem code a0401 captures the reportable event of cutting wire broken.Medical device problem code a051201 captures the reportable event of wire anchor dislodged.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was detached from the working length and the broken section was not returned.The device was observed under magnification and the remaining cutting wire was blackened.The anchor was also seen inside the working length and the distal pierce hole was slightly torn.No other problems with the device were noted.The reported event of cutting wire break was confirmed; however, dislodged wire anchor was not confirmed.The broken cutting wire could have been generated if there was contact between the device and the scope during energization or if the device exceed the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause premature cutting wire fatigue.Also, the working length was torn at the distal pierce hole.This could have been generated by submitting the catheter to tension forces during the handle actuation or when bowing the device without being completely out of the scope.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 used in the papilla during an endoscopic papillotomy (ept) procedure performed on (b)(6) 2022.During the endoscopic sphincterotomy (est) procedure, the physician saw some spark on the cutting wire of the ultratome xl, the wire anchor dislodged and then it just broke.The cutting wire detached inside the patient and then it disappeared.He used the endoscope to check the detached piece; however, he could not find it, so there was not any plan to remove the missing wire.Additionally, the physician was expecting the patient to pass the missing wire.They changed the device and the procedure was completed with 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.

• 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: 14121446
• MDR Text Key: 289433098
• Report Number: 3005099803-2022-01993
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0028197792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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 Sex: Female