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

Model Number M006180156090

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

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 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
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; ,; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8450156
• MDR Text Key: 139807425
• Report Number: 3005099803-2019-01423
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729423829
• UDI-Public: 08714729423829
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1