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

Model Number	M0061802230
Medical Device Problem Codes	Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of material deformation.
Event or Problem Description
It was reported to boston scientific corporation that a contour stent device was used under local anesthesia during a cystoscopy procedure.During insertion, the stent became distorted and could not be successfully inserted.A new stent was used to complete the procedure.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of material deformation.Block h11: investigation analysis: upon receipt at our quality assurance laboratory, this contour device underwent a thorough analysis.Visual analysis identified that the bladder coil was kinked in two sections, the stent renal was buckled, and the shat was torn.The positioner was returned for analysis.The reported event of stent material deformation was confirmed.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, it is possible to conclude that this issue could be caused by operational factors.Probably, there were some manipulations during the procedure could have caused the damage of torn or buckled.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a contour stent device was used under local anesthesia during a cystoscopy procedure.During insertion, the stent became distorted and could not be successfully inserted.A new stent was used to complete the procedure.The patient condition following the procedure was stable.

• 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: 23624806
• Report Number: 2124215-2025-85741
• Device Sequence Number: 8977653
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: (01)08714729058533(17)280224(10)35924463
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0035924463
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG