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

Model Number M0063903200

Device Problems Peeled/Delaminated (1454); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nitinol retrieval coil device was about to be use during a ureteral calculi procedure performed on (b)(6) 2024.During preparation, the part of the coil turning to a basket was kinked and fractured.Additionally, the coating peeled off from the inner core wire of the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a040506 captures the reportable coating fractured.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19076577
• MDR Text Key: 339797807
• Report Number: 2124215-2024-21528
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

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 Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0008597090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 62 KG