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

Model Number	M006180223090
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported by the distributor.The physician is: (b)(6).(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6) 2021.During unpacking, it was noticed that the stent seemed to be separated.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
The event was reported by the distributor.The physician is: dr.(b)(6).Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned contour ureteral stent was analyzed, and a visual evaluation noted that the stent was found with the bladder pigtail detached (the detached section was missing).The suture string and the positioner did not returned for the analysis.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, it was found with the bladder pigtail detached, this problem could have been generated due to the technique of the physician with an excess of force and the anatomy of the patient could contributed with the cause of the failure; also, it is important to mention that the detached section and the suture string did not returned that is aligned with the interaction of the device with the suture string, when it is pull out with an excess of force damaging the performance of the catheter.Since the adverse event occurred during the procedure and the device had no influence on event.Therefore, adverse event related to procedure 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.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6) 2021.During unpacking, it was noticed that the stent seemed to be separated.Another contour ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12500826
• Report Number: 3005099803-2021-04888
• Device Sequence Number: 19810319
• Product Code: FAD
• UDI-Device Identifier: 08714729424062
• UDI-Public: 08714729424062
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 03/28/2024
• Device Model Number: M006180223090
• Device Catalogue Number: 180-223-09
• Device Lot Number: 0027784616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1