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

Model Number M0061802230

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a contour ureteral stent was used during a ureteral lithotripsy procedure in the urethra performed on (b)(6) 2023.During insertion, it was noted that the stent could not be delivered.The procedure was successfully completed with another contour ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the stent was buckled/accordioned, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

Manufacturer Narrative

Block e1: (b)(6) hospital.Block h6: imdrf device code a0406 captures the reportable investigation results of stent buckled/accordioned.Block h10: the returned contour ureteral stent was analyzed, and a magnification and visual evaluation noted that the bladder coil was buckled.A media inspection was performed and noted that one of the photos shows no damages in the device.And the other photo shows that the box of the contour stent was opened.During functional inspection, a mandrel 0.039 was loaded into the device and no resistance was felt.However, due to the condition of the device, the result of the functional failed.No other problems with the device were noted.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that this problem could be caused by operational factors.Interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure.This could have contributed to the failure, consistently leading to device being buckled.Consequently, affect the performance of the device.Also, there was no resistance felt, however, the buckled found in the device could lead the device to the reported issue difficult to advance.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.

• Brand Name: CONTOUR
• Type of Device: 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: 18419092
• MDR Text Key: 331616056
• Report Number: 3005099803-2023-06901
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: 08714729058533
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0029433958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 50 KG