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

Model Number	180-223
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material.Block h11: correction to block e1: initial reporter address 1, initial reporter address 2, initial reporter city and initial reporter zip/post code.
Event or Problem Description
It was reported that a contour ureteral stent was used during a ureterolithotripsy procedure, and, during the procedure, when the device was inserted inside the patient, it was noted that the stent had wrinkles and could not be inserted any further.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 ureteral stent was used during a ureterolithotripsy procedure, and, during the procedure, when the device was inserted inside the patient, it was noted that the stent had wrinkles and could not be inserted any further.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material.Upon receipt at our quality assurance laboratory, this contour stent underwent a thorough analysis.Visual analysis identified that the stent was buckled and both stent coils were torn.Based on the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors since, the positioner has to be loaded by the radiopaque tip of the positioner onto guidewire and advance until it abuts the stent.The positioner was advanced with excess force over the guidewire resulting for the stent to get buckled/accordioned, resulting to, difficulty/unable to advance the stent to the target site.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a contour ureteral stent was used during a ureterolithotripsy procedure, and, during the procedure, when the device was inserted inside the patient, it was noted that the stent had wrinkles and could not be inserted any further.The procedure was completed with another of the same device and there were no patient complications reported.

• Brand Name: CONTOUR
• 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: 21106896
• Report Number: 2124215-2024-82938
• Device Sequence Number: 12749463
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: 08714729058533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2025

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: 180-223
• Device Catalogue Number: 180-223
• Device Lot Number: 0033203888
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 02/13/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/27/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 67 KG