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

Model Number	M0061805320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(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 stent was implanted in the left ureter, in a procedure performed on (b)(6) 2019.According to the complainant, post procedure during withdrawal, on an unknown date, it was noticed that the stent was broken.The broken stent was explanted and another type of stent was implanted.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.Device code 1069 captures the reportable event of stent shaft broken.A visual evaluation of the returned device found that the stent shaft section was torn.The torn was perceived as broken; consequently confirming the reported complaint.The suture string was returned properly cut.Based on the product analysis, the failure was noted during post procedure.There were no defects reported by the user during the unpacking, preparation and introduction.Therefore, the failure found (stent torn) was an issue that could have been generated by the user or due to the interacting of the device with the suture string or other devices used in the same procedure.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a contour stent was implanted in the left ureter, in a procedure performed on (b)(6) 2019.According to the complainant, post procedure during withdrawal, on an unknown date, it was noticed that the stent was broken.The broken stent was explanted and another type of stent was implanted.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8523367
• Report Number: 3005099803-2019-02010
• Device Sequence Number: 19501995
• Product Code: FAD
• UDI-Device Identifier: 08714729285564
• UDI-Public: 08714729285564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: 08/07/2021
• Device Model Number: M0061805320
• Device Catalogue Number: 180-532
• Device Lot Number: 0022485523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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