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

Model Number	M0061802230
Medical Device Problem Codes	Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device problem code a040601 captures the reportable event of stent buckled.
Event or Problem Description
It was reported that, during a percutaneous nephrolithotomy procedure, when the physician placed the contour ureteral stent over a sensor wire, the stent was stuck onto the sensor wire and became buckled.The physician had to cut the stent and wire to be removed.Reportedly, the guidewire was advance in and out of the urethra that might have caused the guidewire to become frayed when it was clamped and leading the stent to be stuck onto the guidewire.Another of the same stent and guidewire were used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that, during a percutaneous nephrolithotomy procedure, when the physician placed the contour ureteral stent over a sensor wire, the stent was stuck onto the sensor wire and became buckled.The physician had to cut the stent and wire to be removed.Reportedly, the guidewire was advance in and out of the urethra that might have caused the guidewire to become frayed when it was clamped and leading the stent to be stuck onto the guidewire.Another of the same stent and guidewire were used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device problem code a040601 captures the reportable event of stent buckled.Block h10: the contour ureteral stent was not returned; however, a photo of the complaint device showed one piece of the cut stent that looks buckled accordion over the guidewire.Additionally, one small part of the piece looks detached from the buckled part of the stent.The suture and positioner were not visible.Moreover, the visible part of the guide wire looks unraveled.The analysis performed to the photo attached, evidence of a stent buckled material.It could be related with the interaction between the guidewire and the stent since the visible part of the wire looks unraveled, this unraveled could generate the difficulty to advance over it generating the buckled material.Additionally, the event mentioned that the physician had to cut the stent and wire to remove, confirming the reported device customer altered product.The additional detachment found, it is possible to concluded 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 is removed using excess force, the stent can get "detached" during the preparation affecting the performance of the device.Based on the analysis results of observed adverse event related to procedure was assigned to this investigation.

• 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: 19898352
• Report Number: 2124215-2024-47784
• Device Sequence Number: 6888342
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: 08714729058533
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: 0032630227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 10/13/2023
• 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 Age: 78 YR
• Patient Sex: Female