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

Model Number M00535900

Device Problem Break (1069)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a0401 captures the reportable event of cutting wire broken.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2023.During preparation outside the patient, it was noticed that "the wire was missing from the front tip needle." the procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and showed the cutting wire was missing at the distal section of the device.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken, and it was not returned.Per media analysis on the provided photo, it showed the device was inside the pouch; however, it was not clear to identify any possible problem or damage that contribute to the reported event.The device was observed under magnification, and the cutting wire was broken, the proximal end of the broken wire was blackened.The unit was cut, in order to check the anchor, and then it was identified that the anchor had remnants of the cutting wire, which suggests that the cutting wire was attached to the anchor.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, and blackened.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.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 during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2023.During preparation outside the patient, it was noticed that "the wire was missing from the front tip needle." the procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and showed the cutting wire was missing at the distal section of the device.

• 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: 16625225
• MDR Text Key: 312103427
• Report Number: 3005099803-2023-01570
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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 Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0029666538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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