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

Model Number	M006180156190
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of coil detached, inside the patient.
Event or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2024-24260
• Device Sequence Number: 20797207
• Product Code: FAD
• UDI-Device Identifier: 08714729765837
• UDI-Public: 08714729765837
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown