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

Model Number	M0061801550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a contour stent was to be used in a ureteric stent placement procedure, and, during unpacking, the stent was found folded and cut.A photo of the device showed that the stent shaft was broken.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a contour stent was to be used in a ureteric stent placement procedure, and, during unpacking, the stent was found folded and cut.A photo of the device showed that the stent shaft was broken.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.Upon receipt at our quality assurance laboratory, this contour vl ureteral stent underwent a thorough analysis.Visual analysis of the device did not reveal any damages and issues.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, the reported allegation of stent shaft break could not be performed through product analysis.A conclusion code of no problem detected was assigned to this investigation.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20994568
• Report Number: 2124215-2024-80871
• Device Sequence Number: 12812569
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Model Number: M0061801550
• Device Catalogue Number: M0061801550
• Device Lot Number: 0034481369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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