MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR VL; STENT, URETERAL

Model Number M006180156190

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of coil detached, inside the patient.

Event Description

It was reported that during the procedure, the tip of the stent was found broken.It was noted that the stent and the broken tip was removed from patient.The procedure was completed with another device and there were no patient complications.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: CONTOUR VL
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19160797
• MDR Text Key: 340924731
• Report Number: 2124215-2024-24260
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729765837
• UDI-Public: 08714729765837
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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: M006180156190
• Device Catalogue Number: 180-156-19
• Device Lot Number: 0033441745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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