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

Model Number	M006180156010
Medical Device Problem Codes	Break (1069); Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a retrograde intrarenal surgery procedure in the ureter, performed on (b)(6) 2021.During preparation, when the nurse pulled out the suture from the stent, the stent shaft broke.Another contour vl ureteral stent was opened and successfully completed the procedure.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.A photo of the complaint device was provided and showed that the stent shaft was broken.
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 a contour vl ureteral stent was used during a retrograde intrarenal surgery procedure in the ureter, performed on (b)(6) 2021.During preparation, when the nurse pulled out the suture from the stent, the stent shaft broke.Another contour vl ureteral stent was opened and successfully completed the procedure.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.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned contour vl stent was analyzed, and a visual evaluation noted that the suture hole torn and the bladder pigtail detached separated.The suture string was loaded in the detached section, the positioner returned with the device only the stabilizer did not return.There was one picture attached in the record.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, if the suture string/retrieval line is intended to be removed before procedure the ifu states that the retrieval line may be cut prior to stent placement.Remove retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull on the retrieval line.According the time of event, it occurred in preparation/prior to sedation meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with a stent coil detached and suture hole torn/ripped.Therefore, failure to follow instruction 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 13196918
• Report Number: 3005099803-2022-00026
• Device Sequence Number: 17222382
• 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,Followup
• Report Date (Section B): 02/21/2022

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: 09/02/2024
• Device Model Number: M006180156010
• Device Catalogue Number: 180-156-01
• Device Lot Number: 0026200137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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: 42 YR
• Patient Sex: Male