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

Model Number M0063903200

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the device was fractured during the use of a laser.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code a0501 captures the reportable event of coil break/fractured.Block h10: the returned stone cone was analyzed, and a visual evaluation noted that the coil was detached at the distal end of the working length.There were burn marks and signs of laser damage at the spot where the coil was detached.The detached coil was returned in two pieces as the laser damage caused a small piece to separate.The reported event was confirmed.Based on all available information, the analyzed condition of the device provides clear evidence that it was fired upon by the laser.The instructions for use (ifu) warns the user "do not fire upon the device with a laser." therefore, the most probable root cause is unintended use error.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a ureteroscopy procedure performed on may 24, 2021.During the procedure, the device was fractured during the use of a laser.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: STONE CONE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12016003
• MDR Text Key: 256714640
• Report Number: 3005099803-2021-02894
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 06/07/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1