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

Model Number M00535920

Device Problems Break (1069); Failure to Conduct (1114); Difficult to Remove (1528)

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

Event Date 04/09/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the ampulla and bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the physician positioned the ultratome xl in the ampulla to perform sphincterotomy.He energized the wire; however, he noticed that the wire would not cut despite energizing the wire multiple times.The device was removed from the duodenoscope with difficulty, so he had to pull it hard.It was noticed that the cutting wire was broken.The elevator channel of the duodenoscope did not close anymore despite multiple efforts to close it and the duodenoscope had to be carefully extracted from the patient with the elevator channel in an open state.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient had to undergo a bile duct surgery, which was not related to this procedure.During that surgery, the stones present in the bile duct were removed.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of cutting wire 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: 17139610
• MDR Text Key: 317767983
• Report Number: 3005099803-2023-03222
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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: 0029629399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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