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

Model Number M00535900

Device Problems Break (1069); Crack (1135); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the distributor.The physician is: (b)(4).(initial reporter address 2): (b)(6).(b)(4).The returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and kinked.The working length was free from obvious kinks and bends; however, the distal pierced hole was slightly torn.These findings were consistent with the findings when the device was observed under magnification.Additionally, the tip of the device was cracked.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken, blackened, and kinked.The cutting wire being blackened indicates that the device was energized.These conditions 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 procedure.Energizing the device prior to performing sphincterotomy can also compromise the cutting wire's integrity and can cause a premature cutting wire fatigue, leading to a break.Upon removing the device from the endoscope, the cutting wire could have been kinked and the working length torn.Additionally, the tip of the device was cracked which could have been due to interaction with the scope, if attempts were made to advance the device through a difficult anatomy, or if the tip was hit against a hard surface.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and integrity.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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the tip end of the of the device was deformed.It was reported that the tip end was kinked.The procedure was completed 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.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.Please refer to block 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
• 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: 13011778
• MDR Text Key: 285742189
• Report Number: 3005099803-2021-06407
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0025850143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG