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

Model Number M00535920

Device Problems Break (1069); Failure to Conduct (1114); Material Deformation (2976)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken, kinked, and blackened on the tip which were consistent to the findings when the device was observed under magnification.A functional evaluation was not performed due to the device condition.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused due to constant energization applied to the device, causing fatigue and eventually the cutting wire to break.This could also generate if the device was activated when in an incorrect position or when in contact with other medical devices.Additionally, the cutting wire was kinked.This condition could have been caused by the interaction with other devices or due to the manipulation of the device.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 during a stone removal procedure performed on (b)(6) 2021.During the procedure, the electric current did not work.The procedure was completed with a different 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 good.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a0401 captures the reportable investigation results of wire break.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken, kinked, and blackened on the tip which were consistent to the findings when the device was observed under magnification.A functional evaluation was not performed due to the device condition.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused due to constant energization applied to the device, causing fatigue and eventually the cutting wire to break.This could also generate if the device was activated when in an incorrect position or when in contact with other medical devices.Additionally, the cutting wire was kinked.This condition could have been caused by the interaction with other devices or due to the manipulation of the device.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.Block h2 (additional information): block e1 (initial reporter phone) has been updated based on additional information received september 23, 2021.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used during a stone removal procedure performed on (b)(6) 2021.During the procedure, the electric current did not work.The procedure was completed with a different 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 good.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.Please refer to block h10 for full investigation details.

• 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: 12506653
• MDR Text Key: 272485826
• Report Number: 3005099803-2021-04911
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2022
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0025489968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1