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

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Defective Device (2588); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device found the leading tip and distal part of coil were completely stripped of coating and the coil was deformed.The tip of the device was missing and the exposed end appeared to be melted and discolored.Based on all available information, it is most likely that the user fired upon the coil with a laser causing it to detach and had to remove the coating of the coil in order to remove the device.The tip of the device was missing, including part of the coil and the distal tip of the device, and melting and discoloration was evident.The found damage was consistent with laser damage.The directions for use 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 unintended use error caused or contributed to event.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 nitinol retrieval coil was used during a transurethral lithotomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the coil was difficult to open and close.Additionally, it was reported that a part of the device was damaged.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The investigation results revealed the coil/cone peeled/sheared and the tip separated; therefore, this is now an mdr reportable event.

• 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: 10445448
• MDR Text Key: 219499055
• Report Number: 3005099803-2020-03412
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 08/24/2020

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: 10/14/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0003952318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1