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

Model Number	M0061801550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018, as no event date was reported.  (b)(4) captures the reportable event of  stent broken.  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 vl ureteral stent was used during a procedure on an unknown date.According to the complainant, during unpacking, the stent was found to be broken.There were no serious injury or adverse patient effect reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.Problem code 1069 captures the reportable event of stent broken.A contour stent was returned for analysis.A visual evaluation of the returned device revealed that the middle section of the was detached.Additionally, the bladder pigtail was observed detached.The most proximal section of the stent and the suture string were not returned for analysis.The failure found (stent detached) is 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 vl ureteral stent was used during a procedure on an unknown date.According to the complainant, during unpacking, the stent was found to be broken.There were no serious injury or adverse patient effect reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: CONTOUR VL
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8131275
• Report Number: 3005099803-2018-61783
• Device Sequence Number: 252084
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 11/12/2020
• Device Model Number: M0061801550
• Device Catalogue Number: 180-155
• Device Lot Number: 0021377886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1