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

Model Number M00535900

Device Problems Defective Device (2588); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned ultratome xl was analyzed, and a visual evaluation noted that the working length was twisted and the distal pierced hole was torn which displaced the cutting wire anchor from it's original position.A functional evaluation noted that a test guidewire could not pass through the distal tip due to the wire anchor being dislodged.Additionally, water flowed through the injection port as intended and the resistance across the 2-in-1 connector and cutting wire were within specification.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the distal pierce hole was torn and the working length twisted causing the cutting wire anchor to displace and tear the catheter.Additionally, a test guidewire was not able to pass through the distal tip due to the wire anchor being dislodged.Based on the condition of the device the failure found could had been generated due to factors encountered during the procedure, the technique used, the patient anatomy and the interaction with the scope, also if the device was actuated in coil 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 directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultratome xl was used in a procedure on (b)(6) 2019.According to the complainant, it was noted that the material was defective.No further information has been obtained despite good faith efforts.This event has been deemed a reportable event based on the investigation results: wire anchor dislodged/dislocated.

• 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: 10478621
• MDR Text Key: 205489088
• Report Number: 3005099803-2020-03581
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: M00535900
• Device Catalogue Number: 3590
• Device Lot Number: 0023612672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1