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

Model Number M0063903200

Device Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a stone cone retrieval coil was returned for analysis.A visual analysis of the returned device found that the blue/green heat shrink at the distal tip is detached from/not flush with the distal stop.No other damages were noted to the blue sheath, white heat shrink, or coil.There were no kinks noted along the working length of the nitinol core wire.The distal stop was not overridden.A functional assessment was performed.The device functioned as intended.There were no issues noted with opening or closing of the coil.For the failure found of blue/green heat shrink at the distal tip found detached from/not flush with the distal stop, and based on all gathered information, the complaint investigation conclusion code selected for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the 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.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter for a upper ureteroscope stone procedure performed on (b)(6) 2018.According to the complainant, during procedure, it was noticed that the stone cone couldn't be open.The procedure was completed with another stone cone nitinol retrieval coil.There was no serious injury nor were there any adverse patient effects reported as a result of this event.This event has been deemed a reportable event based on the investigation results; coil/cone peeled/shared.

• 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; 1525 hertz street; chihuahua ; MX
• Manufacturer Contact: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8369961
• MDR Text Key: 137157829
• Report Number: 3005099803-2019-00951
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/26/2019

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: 12/06/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0004023644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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
• Patient Age: 54 YR
• Patient Weight: 55