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

Model Number	M006180156090
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl stent was to be used for an unknown procedure, on an unknown date.According to the complainant, when being removed from the shelf, the packaging of the stent was noticed to be damaged.The procedure was completed successfully with the use of another contour vl stent.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: 8450156
• Report Number: 3005099803-2019-01423
• Device Sequence Number: 2926094
• Product Code: FAD
• UDI-Device Identifier: 08714729423829
• UDI-Public: 08714729423829
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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: 02/28/2021
• Device Model Number: M006180156090
• Device Catalogue Number: 180-156-09
• Device Lot Number: 0022203833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1