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

Model Number	M0061801550
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation results of stent detached, stent buckled and stent torn, inside the patient.Block h10: the returned contour vl ureteral stent was analyzed, and a visual evaluation noted that the stent coil was buckled accordion, torn, bent or kinked and detached or separated.During functional inspection, the mandrel 0.036 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event was not confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Most likely, the issue was caused due to there was an excess of force applied over the device when it was used, probable at the time to try inserted it in the guide wire.These factors could have generated the stent knotted and that was observed.Consequently, affected the performance of the device.Therefore, the as root cause code will be adverse event related to procedure.For the reported issue stent knotted, it is not confirmed since it was not detected.The root cause code will be no problem detected.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific that a contour vl ureteral stent was used during a procedure in the ureter performed on (b)(6) 2022.During the procedure, the stent was tangled with guide wire.The procedure was successfully completed with another contour vl ureteral stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent detached, stent buckled and stent torn, inside the patient, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation results of stent detached, stent buckled and stent torn, inside the patient.Block h11: it was noted on 10aug2023, upon further review of product investigation, the event reported under mfr report number 3005099803-2023-03991 was sent in error.Product investigation indicates that the contour stent break was clarified to be coil detached, outside the patient occurred.Therefore, this is considered non reportable.
Event or Problem Description
It was reported to boston scientific that a contour vl ureteral stent was used during a procedure in the ureter performed on (b)(6) 2022.During the procedure, the stent was tangled with guide wire.The procedure was successfully completed with another contour vl ureteral stent.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: 17455405
• Report Number: 3005099803-2023-03991
• Device Sequence Number: 2531028
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/14/2023

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: 11/14/2024
• Device Model Number: M0061801550
• Device Catalogue Number: 180-155
• Device Lot Number: 0028388902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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