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

Model Number	M006180156010
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	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned contour vl ureteral stent was analyzed, and a visual evaluation noted that at the first view, the stent was with their bladder pig tail buckled or accordion, and several torn in the same pig tail side port holes and suture hole.Additionally, the suture and positioner did not return.Then during the functional inspection, it pass through the stent successfully, no resistance was felt.Finally, during the magnification observed closely the found issue in the bladder coil.Additionally, the side port holes and suture hole were observed torn and stretch out, besides the tip was found torn.Moreover found some residues as part of the procedure in the bladder pig tail.No other problem 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.It was found that a bladder pig tail is buckled accordion and torn, also observed that side port holes are stretch out such as torn.Additionally, some kind residues as part of the procedure were observed in the bladder pig tail, indicating that the stent was used.Therefore, the most probable cause of those failures is no problem detected since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6) 2022.During the preparation, it was noted that they had difficulty inserting the stent through the guidewire.The procedure was successfully completed with another contour vl 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, therefore this event has been deemed an mdr reportable 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: 15544585
• Report Number: 3005099803-2022-05605
• Device Sequence Number: 6502434
• Product Code: FAD
• UDI-Device Identifier: 08714729067993
• UDI-Public: 08714729067993
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Report Date (Section B): 10/05/2022

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: 08/08/2025
• Device Model Number: M006180156010
• Device Catalogue Number: 180-156-01
• Device Lot Number: 0028169633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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 Age: 62 YR
• Patient Sex: Male