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

Model Number M00535900

Device Problems Break (1069); Failure to Fold (1255); Material Deformation (2976)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code (b)(6) captures the reportable event of cutting wire broken.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The device was opened, and it was inserted through the working channel of the duodenoscope.During the procedure, to start the sphincterotomy, the handle was actuated; however, a resistance was felt.It was found that the pull wire from the handle was broken.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the pull wire in the handle was broken and kinked.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The device was opened, and it was inserted through the working channel of the duodenoscope.During the procedure, to start the sphincterotomy, the handle was actuated; however, a resistance was felt.It was found that the pull wire from the handle was broken.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint device outside the patient were provided by the customer and showed the pull wire in the handle was broken and kinked.

Manufacturer Narrative

Imdrf device code a0401 captures the reportable event of cutting wire broken.The returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken and kinked at the handle section, which are consistent with the media evaluation.Per the x-ray inspection, the working length was kinked at the hypotube position.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 kinked at the handle section, and the working length was kinked at the hypotube position.Based on the condition of the device, it is most likely that handling and manipulation of the device during use can lead to bending of the working length at the proximal section.Probably, the kink at the proximal section could have caused some internal tension forces between the cannula and the wire during the handle actuation and this condition could affect the overall performance of the device and lead to breaking it.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.

• 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: 16507948
• MDR Text Key: 311247951
• Report Number: 3005099803-2023-01232
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 06/20/2023

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: 0030411285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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