MAUDE Adverse Event Report: EV3 / MEDTRONIC, INC. PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	SERB65-10-40-80
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lumen device didn't open up as scrub staff tested device on sterile field.Device didn't reached patient yet.A new stent was opened and used for the procedure.Fda safety report id # (b)(4).

• Brand Name: PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): EV3 / MEDTRONIC, INC.; plymouth MN 55442 2920
• MDR Report Key: 11404200
• Report Number: MW5099737
• Device Sequence Number: 4523269
• Product Code: FGE
• UDI-Device Identifier: 00643169729056
• UDI-Public: (01)00643169729056(17)230223
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: 02/23/2023
• Device Model Number: SERB65-10-40-80
• Device Catalogue Number: SERB65-10-40-80
• Device Lot Number: A981529
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1