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

Model Number	M006180156120
Medical Device Problem Codes	Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of a stent buckled.
Event or Problem Description
It was reported that, during a ureteric stent placement procedure a contour vl ureteral stent was used, the stent was inserted over the guidewire with a pusher to push the stent over the wire.It was observed that the stent crimpled the wire and the wire could not be retracted.The stent and the guidewire were removed by pulling antegradely.Another new stent and guidewire were used to complete the procedure.

• 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: 20926224
• Report Number: 2124215-2024-78593
• Device Sequence Number: 17404106
• Product Code: FAD
• UDI-Device Identifier: 08714729423843
• UDI-Public: 08714729423843
• 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
• Report Date (Section B): 12/13/2024

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 Model Number: M006180156120
• Device Catalogue Number: 180-156-12
• Device Lot Number: 0034624348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 05/10/2024
• 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