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 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 during a procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the ultratome xl broke in the area of the shaft and which caused considerable damage to the duodenoscope.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block e1 (initial reporter phone): (b)(6).Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.

Manufacturer Narrative

Block e1 (initial reporter phone): (b)(6) block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.Block h2 (additional information): block b3, block b5, block h6 (impact codes and device codes), block d7a, and block h8 have been updated based on the additional information received on june 15, 2023.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during a procedure performed on (b)(6) 2023.During the procedure, the cutting wire of the ultratome xl broke in the area of the shaft and which caused considerable damage to the duodenoscope.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.Additional information received on june 15, 2023: the ultratome xl was used in the bile duct and ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.It was reported that the wire anchor of the ultratome xl dislodged.Additionally, no part of the cutting wire detached and fell into the patient.The procedure was not completed as there was only one duodenoscope.The patient underwent a bile duct surgery at a later date, which was not related to this complaint, and the stones present in the bile duct were removed as well during that surgery.There were no patient complications reported as a result of this event.

• 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: 17066036
• MDR Text Key: 316766932
• Report Number: 3005099803-2023-03003
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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: 06/15/2023
• 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