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

Model Number	M0061802230
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled.
Event or Problem Description
It was reported that, during a lithotripsy for left ureteral calculi procedure a contour ureteral stent was used.When the stent was inserted, the stent became buckled and could not be inserted into the ureter smoothly.Another of the same stent was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
H6: imdrf device code a040601 captures the reportable event of stent buckled.H11: the returned contour ureteral stent was analyzed, during the inspection, some tears found on the renal coil.However, the coils and the stent shaft were in good condition.Also, a sensor wire of 0.038 in was inserted into the stent to evaluate if some resistance was felt inside the device, however, no resistance was felt during the analysis performed.However, during the inspection, it was found some tears on the renal coil that was not related to the reported events.Regarding to the analysis performed to the returned device, it is possible to conclude that this problem could be caused by operational factors.Probably, some manipulation during the procedure could have caused the tears observed on the renal coil.For that reason, this issue will be documented as "adverse event related to procedure".Based on the analysis results, the most probable cause is "no problem detected" since it was not possible to identify any evidence of the alleged issues on the device.
Event or Problem Description
It was reported that, during a lithotripsy for left ureteral calculi procedure a contour ureteral stent was used.When the stent was inserted, the stent was wrinkled and could not be inserted into the ureter smoothly.Another of the same stent was used to complete the procedure.No patient complications were 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: 20824702
• Report Number: 2124215-2024-75604
• Device Sequence Number: 12725493
• 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
• Report Date (Section B): 01/22/2025

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 Expiration Date: 10/03/2026
• Device Model Number: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0032563268
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: Male