MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number	H74938046730750
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During pre-op inspection, stent got caught over wire.Unable to advance or remove stent on wire.This did not reach the patient.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8707084
• Report Number: 8707084
• Device Sequence Number: 2073108
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: (01)08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/29/2019
• Report Date (Section F): 05/29/2019

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 Model Number: H74938046730750
• Device Catalogue Number: H74938046730750
• Device Lot Number: 21237716
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95
• Date Report Sent to FDA: 05/29/2019