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 Consequences Or Impact To Patient (2199)

Event Date 09/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 was to be used in the ureter during a ureterolithiasis procedure performed on (b)(6) 2020.According to the complainant, during preparation, when the device was unpacked, the coil was found fractured.Another stone cone was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 2907 captures the reportable event of coil detached.Block h10: visual analysis of the returned device found the distal portion of the coil and the leading tip of the device was detached which confirms the reported event.The section of the coil that was detached was separated from its coating and scorching was evident on the exposed tip.Based on all available information, it is most likely that the user fired upon the coil with a laser causing it to detach.The instructions for use (ifu) states "warning: to minimize risk of device breakage or patient injury, do not fire laser directly on any part of the stone cone coil.Warning: do not set holmium laser energy above.8 joules or power setting over 8 watts." therefore, the most probable root cause is failure to follow instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed, and there is no evidence that the device was used not in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a stone cone was to be used in the ureter during a ureterolithiasis procedure performed on (b)(6) 2020.According to the complainant, during preparation, when the device was unpacked, the coil was found fractured.Another stone cone was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 10720652
• MDR Text Key: 212560034
• Report Number: 3005099803-2020-04798
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005040626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 53