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

Model Number	M0063903100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact patient age unknown, but reported to be over 18 years of age.Initial reporter address 1: (b)(6).(b)(4).Visual analysis found the device was returned in three separate pieces.The blue outer sheath was completely detached from the device and arrived as its own piece.The inner working length arrived as a separate piece.The coil was detached and the leading tip of the device arrived as the third piece.Additionally, the coil was tangled and the exposed tip contained scorching on one side, which is consistent with laser damage.Based on all available information, it is most likely that the device was fired upon with a laser, as evident from the scorching on the tip of the coil.This could have caused the device to have issue recoiling properly and becoming tangled, resulting in the device being disassembled.The direction for use (dfu) states not to fire upon the device with a laser.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 or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the medial ureter during a lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stone cone was inserted into the ureter.However, the device was unable to form a coil and became deformed.The procedure was completed with another stone cone device.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.Investigation results revealed the coil was detached; therefore, this is now an mdr reportable 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: 10249884
• Report Number: 3005099803-2020-02583
• Device Sequence Number: 19021073
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 07/09/2020

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: 10/07/2022
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0005089380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1