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

Model Number	M006180156090
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 an contour ureteral stent was used during a ureteral stent implantation procedure in the urinary tract, performed on (b)(6) 2022.During the procedure, when the stent was pushed into the guidewire, the stent became buckled/accordioned and resistance was observed.Another contour 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 h6: medical device problem code a0406 captures the reportable code of stent buckled material.Block h10: the returned contour vl ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail was buckled.Moreover, under magnification, it was observed that the tip was torn and stretched.A functional evaluation noted that a mandrel 0.038" was loaded into the device and no resistance was felt.No other issues with the device were noted.The reported event was confirmed.According to product analysis, the device found with the bladder pig tail buckled accordion, moreover, the tip was found torn and stretched.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.Therefore, adverse event related to procedure is selected as the 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.
Event or Problem Description
It was reported to boston scientific corporation that an contour ureteral stent was used during a ureteral stent implantation procedure in the urinary tract, performed on (b)(6)2022.During the procedure, when the stent was pushed into the guidewire, the stent became buckled/accordioned and resistance was observed.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• 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: 14077497
• Report Number: 3005099803-2022-01792
• Device Sequence Number: 2121786
• Product Code: FAD
• UDI-Device Identifier: 08714729423829
• UDI-Public: 08714729423829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/26/2022

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: 10/24/2024
• Device Model Number: M006180156090
• Device Catalogue Number: 180-156-09
• Device Lot Number: 0028831506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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