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

Model Number	M0061802240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(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 ureteral stent was used during a stent placement procedure in the ureter and bladder.The exact event date was not reported.According to the complainant, during the procedure, when the physician removed the device from the package, the stent shaft was found to be broken.The procedure was successfully completed with another contour ureteral stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used during a stent placement procedure in the ureter and bladder.The exact event date was not reported.According to the complainant, during the procedure, when the physician removed the device from the package, the stent shaft was found to be broken.The procedure was successfully completed with another contour ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code 1069 captures the reportable event of stent shaft broken.Block h10: the returned contour ureteral stent was analyzed, and a visual evaluation noted that the middle section detached/separated.The suture string was not returned for analysis.No other issues with the device were noted.The reported event of stent shaft broke was confirmed.The stent was returned without the suture string, evident that the stent was manipulated.The failure found (catheter detached) is an issue that could have been generated by the user or due to the interacting of the device with the suture string.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.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
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10163365
• Report Number: 3005099803-2020-02343
• Device Sequence Number: 3573258
• Product Code: FAD
• UDI-Device Identifier: 08714729058564
• UDI-Public: 08714729058564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 07/16/2022
• Device Model Number: M0061802240
• Device Catalogue Number: 180-224
• Device Lot Number: 0024122106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1