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

Model Number	M0063903100
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional 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 medwatch will be filed.
Event or Problem 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) 2020.According to the complainant, during the procedure, the sheath on the distal tip of the coil detached into the patient.The detached part had flushed out naturally from the patient's body and the procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 1454 captures the reportable event of the plastic cover on the distal tip of the device fell off.Block h10: visual inspection of the returned device found that the leading tip of the device was detached and not returned.A small amount of device that remained past the distal stop was missing the coating and scorching was evident on the exposed tip.The working length was also kinked and the coil was unable to be sheathed.Based on all available information, it is 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 direction for use (dfu) 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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem 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) 2020.According to the complainant, during the procedure, the sheath on the distal tip of the coil detached into the patient.The detached part had flushed out naturally from the patient's body and the procedure was completed with this device.There were no patient complications as a result of this event.

• Brand Name: STONE CONE
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10460360
• Report Number: 3005099803-2020-03460
• Device Sequence Number: 2939771
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0005162694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1