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

Model Number	M0061801560
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a ureteroscopy procedure in the common kidney and urinary bladder, performed on (b)(6) 2022.During the procedure, the physician felt a bit of resistance during the initial part of insertion but it was pushed through until during full deployment and it was noticed that the stent was kinked.Another contour vl ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a ureteroscopy procedure in the common kidney and urinary bladder, performed on (b)(6) 2022.During the procedure, the physician felt a bit of resistance during the initial part of insertion but it was pushed through until during full deployment and it was noticed that the stent was kinked.Another contour vl ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: medical device problem code a0406 captures the reportable event of stent kinked inside the patient.Block h10: the returned contour vl ureteral stent was analyzed, and a visual evaluation noted that the suture hole and bladder pig tail tip was deformed.A picture attached in the complaint, the picture shows the device inside of a generic plastic bag.However, is not possible identify any issue due to the picture angle.A functional evaluation noted that a mandrel of 0.038" pass through the stent without resistance.The suture string was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the device found with the suture hole and bladder pig tail tip deformed.It is possible that operational factors, such as the force used when the stent is pushed up with the pusher/positioner over the guidewire or when the stent was used, excess of force applied during it used could cause the found issues.Consequently, affect the performance of the device.It is important mention that the suture hole and the tip deformed could be interpret by the costumer as stent kink.The device was tested and mandrel 0.038" were inserted through the catheter and no resistance was felt and the mandrel was unloaded without issues; for this reason, the report complaint of stent/delivery system difficult to advance cannot be confirmed.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14001918
• Report Number: 3005099803-2022-01648
• Device Sequence Number: 4433137
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: 08714729067986
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 04/28/2022

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: 09/06/2024
• Device Model Number: M0061801560
• Device Catalogue Number: 180-156
• Device Lot Number: 0027977822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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