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

Model Number	M006180155090
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6) hospital.(b)(4).The returned contour ureteral stent was analyzed, and a visual evaluation noted that the catheter proximal section was found with shaft knotted itself and residues of used were observed over it.A functional evaluation noted, a 0.035" mandrel was inserted through the catheter and no resistance was felt until the knot section.No other issues with the device were noted.The reported event was confirmed.The complainant reported that the device was difficult to advance and buckled, however based on the product analysis the stent was found with the shaft knotted at the proximal section.Based on product analysis, and all compiled information, it is possible that the failure found, stent knotted, is an issue that could have been generated by the user or due to the manipulation of the device when the stent was used.The most probable cause of those failures is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure 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.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl ureteral stent was used during a laser ureteroscopy procedure in the ureter performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was stuck on the guidewire and was unable to be advanced.When the stent was pulled out, it became scrunched up.The procedure was successfully completed with another contour vl ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was noted to be stable.Investigation results revealed that the stent coil was knotted, therefore this event has been deemed an mdr reportable event.

• 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: 10059531
• Report Number: 3005099803-2020-01956
• Device Sequence Number: 19672514
• Product Code: FAD
• UDI-Device Identifier: 08714729423768
• UDI-Public: 08714729423768
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 08/20/2022
• Device Model Number: M006180155090
• Device Catalogue Number: 180-155-09
• Device Lot Number: 0024840211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1