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

Model Number M00535900

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 device was used in the papilla of oddi during and endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was a clicking sound with the handle of the device and the angle of the cutting wire was not in a good position in the endoscopic image.The procedure was completed with another ultratome xl 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 okay.

Manufacturer Narrative

Block h6: device code 3009 captures the reportable event of positioning problem.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the device was found in good condition with no visual damage.A functional evaluation noted that the device was correctly oriented when performing the orientation test.No other issues with the device were noted.The reported event was not confirmed.Upon analysis the returned device did not present any visual damage and performed orientation as intended.Additionally, the clicking sound was found to be a result of the active cord movement inside the ring gage nest and does not cause a functional issue.Based on all compiled information, the most probable root cause is no problem detected.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 directions for use (dfu) / product label.

Event Description

It was reported that an ultratome xl device was used in the papilla of oddi during and endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was a clicking sound with the handle of the device and the angle of the catheter and the cutting wire were not in a good position in the endoscopic image.The procedure was completed with another ultratome xl 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 okay.

• 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: 10141630
• MDR Text Key: 194771249
• Report Number: 3005099803-2020-02143
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0024915935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 08/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1