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

Model Number M00535900

Device Problems Break (1069); Defective Device (2588)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultratome xl was used.The ultratome xl was reported to be "defective." there were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.This event has been deemed a reportable event based on the investigation results: detached cutting wire with evidence of lack of welding between the cutting wire and the anchor.

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.(b)(4).The returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was detached from the distal pierced hole, consistent with the finding when the device was observed under magnification.Additionally, the wire anchor was still within the catheter.Per the x-ray images, it was observed that the cutting wire was detached from the wire anchor and there was evidence of lack of welding between the cutting wire and the anchor.No other problems with the device were noted.The product analysis revealed that the cutting wire was detached form the wire anchor.Based on the condition of the device, it could have been generated due to a lack welding, making it difficult or unable to bow, affecting the overall performance of the device.This determined that the problem was probably due to manufacturing deficiency.An investigation to address this issue has been completed.The investigation found that man is considered the most assignable cause of this event.It is possible that the production guide running the notch/cutting wire assembly did not meet the three second immersion time in the chemical flux which is vital for the weld to flow correctly around the entire cutting wire-notch assembly.Additionally, cleaning the cutting wire may not have been executed correctly for these complaint units or the cutting wire may have been reworked due to some defect in the weld, but the cutting wire tip was not cleaned again.Method is not considered a contributing factor as the procedure is clear and has all the necessary indications for the correct execution of the steps of the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 13664845
• MDR Text Key: 286753003
• Report Number: 3005099803-2022-01118
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: 08714729103257
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0024827690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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