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

Model Number	M0061801550
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, the device had difficulty advancing and the problem was identified at the tip of the stent.Procedure completed with another of the same device.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported that during insertion, the device had difficulty advancing and the problem was identified at the tip of the stent.Procedure completed with another of the same device.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable investigation results of stent kinked, inside the patient.The reported event of device difficult to advance and stent kinked will not be confirmed and will be documented as no problem detected.This conclusion was selected because after visual and microscope inspection, and wire insertion test in the complaint device, it was not possible to identify any evidence of the alleged issue on the device, since the stent shaft was in good condition and also the guidewire was able to fully pass through the stent.However, the stent was found with the suture hole torn until the tip.Regarding to the analysis performed to the returned device, the suture did not return indicating that it was removed.This failure could have caused, due to an interaction of the device with the suture string such as entanglement and manipulation or excess of force applied over the device.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions, since problems were traced to the user not following the manufacturer's instructions.

• 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: 20678232
• Report Number: 2124215-2024-70662
• Device Sequence Number: 8499390
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 0033990254
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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 Age: 51 YR
• Patient Sex: Female