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

Model Number	M0061801560
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a cotour vl stent was to be used in a ureteroscopy with laser lithoripsy procedure, and, during preparation when the suture was removed for insertion, the stent broke into two pieces along the shaft.The procedure was completed with another stent and there were no patient complications reported.
Event or Problem Description
It was reported that a cotour vl stent was to be used in a ureteroscopy with laser lithoripsy procedure, and, during preparation when the suture was removed for insertion, the stent broke into two pieces along the shaft.The procedure was completed with another stent and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.Upon receipt at our quality assurance laboratory, this contour vl ureteral underwent a thorough analysis.Visual inspection of the device revealed that the stent bladder coil was detached.The pouch and the detached parts were returned.The suture and the positioner were not returned for analysis.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, the reported allegation of stent shaft break could not be confirmed.It is possible to conclude that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder and was removed using excess force, the stent could get detached/separated during the preparation, affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.Correction to block d4: (root parent) unique identifier (udi) #.

• 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: 21620731
• Report Number: 2124215-2025-15429
• Device Sequence Number: 12873276
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: 08714729067986
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: M0061801560
• Device Catalogue Number: M0061801560
• Device Lot Number: 0035133091
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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