MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Difficult to Open or Close (2921)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a transurethral ureteroscopy holmium laser lithotripsy procedure performed on (b)(6) 2022.During the procedure, after opening the cone, it failed to close.The procedure was completed with another stone cone.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.The investigation results revealed the coil/cone peeled/sheared; therefore, this is now an mdr reportable event.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The returned stone cone device was analyzed, and a visual evaluation observed that the blue/green shrink at the distal tip was separated from the distal stop.A functional testing was performed and found the cone was tangled and cannot fully close.Based on all available information, it is most likely that the damage was caused during the testing of device with the use of excessive force or manipulation.This is shown by the separation of the blue/green shrink at the distal part which likely caused the cone to become tangled.Therefore, the most probable root cause is unintended use error.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.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14601784
• MDR Text Key: 293348262
• Report Number: 3005099803-2022-03126
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005716805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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