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

Model Number M00535900

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the ultratome xl was inserted through the endoscope.While bowing the device outside the tip of the endoscope, the cutting wire broke.The procedure was completed successfully using "another device.".There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: photos of the complaint device outside the patient were provided by the customer and showed the cutting wire was broken and kinked.

• 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: 17087166
• MDR Text Key: 316794443
• Report Number: 3005099803-2023-02999
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2023

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: 05/08/2024
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0029367049
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1