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

Model Number M0063903100

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2020

Event Type  malfunction  

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 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
• 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: 10249884
• MDR Text Key: 198359918
• Report Number: 3005099803-2020-02583
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1