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

Model Number	M0061802220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 ureteroscopy procedure in the kidney, performed on (b)(6) 2021.During the procedure and inside the patient, when the physician attempted to implant the stent, it was noticed that the stent broke into pieces.It is unknown on how the broken piece were removed but it was reported that all broken pieces were retrieved from the patient.Another contour ureteral was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent break.Health impact code f23 captures the retrieval of the broken stent pieces.Block h10: the returned contour ureteral stent was analyzed, and a visual evaluation noted that the proximal section bladder pigtail detached.The suture string was returned loaded in the bladder pigtail section detached.No other issues with the device were noted.The reported event was confirmed.According to product analysis, the suture string was returned loaded in the bladder pigtail section detached and uncut, it was evidence of the stent was manipulated out of the package.The problem found is an issue that could have been generated by an excess of force or due to the interacting of the device with the suture string or during the interaction with other devices.This failure is aligned to the suture string interaction/handling/manipulation.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 ureteroscopy procedure in the kidney, performed on (b)(6), 2021.During the procedure and inside the patient, when the physician attempted to implant the stent, it was noticed that the stent broke into pieces.It is unknown on how the broken piece were removed but it was reported that all broken pieces were retrieved from the patient.Another contour ureteral was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11922667
• Report Number: 3005099803-2021-02555
• Device Sequence Number: 922737
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: 08714729058502
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Device Lot Number: 0026836329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention