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

Model Number M00535900

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, after attempts of cannulation, it was noticed that the cutting wire was kinked and the cutting wire orientation was incorrect.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6 (device codes): problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was kinked.Additionally, the distal tip section showed that the working length was torn.The device was observed under magnification and the cutting wire was kinked at the distal tip area, the distal pierced hole was torn, and the anchor was displaced but it is still within the catheter.A functional evaluation noted that the the catheter was correctly oriented when the device was put inside the duodenoscope and when the distal tip of the device extended past the elevator of the duodenoscope.No other problems with the device were noted.The reported complaint of incorrect cutting wire orientation was not confirmed.Upon analysis, it was found that the cutting wire was kinked.This condition could have been caused by applying repetitive additional force to the device when activated or if it was actuated in the wrong position during the procedure.Additionally, the distal pierced hole was torn which could have been caused by resistance when bowing the cutting wire causing the catheter to tear and displace the cutting wire notch from its position.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, after attempts of cannulation, it was noticed that the cutting wire was kinked and the cutting wire orientation was incorrect.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12125068
• MDR Text Key: 260704095
• Report Number: 3005099803-2021-03200
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0025767182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 72