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

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).A stone cone retrieval coil was returned for analysis.A visual analysis of the returned device found that the blue/green heat shrink is pulled away from the distal stop.Furthermore, the coil is kinked at the distal stop.No other anomalies were noted.A functional assessment was performed, and the device was found to be able to open and close freely.It is likely that during unpacking and preparation, the user failed to follow the directions for use by applying excessive force when advancing the blue sheath over the coil, resulting in the coil kinking and the blue/green heat shrink separating from the distal stop.Therefore, the complaint investigation conclusion code selected for this event is failure to follow instructions, which indicates that problems were traced to the user not following the manufacturer's 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 no anomalies were noted.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in a procedure on (b)(6) 2018.According to the complainant, during preparation, it was noticed that the shape of the device changed and the wire seemed to be stretched.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: 8226827
• MDR Text Key: 132412271
• Report Number: 3005099803-2018-62415
• 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: Physician
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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: 63445
• Device Lot Number: 0003952318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2017
• 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