MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VALEO® BALLOON EXPANDABLE BILIARY STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	EV06181CD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While positioning stent in patient the stent came off the balloon.Stent was lodged in the sheath requiring sheath and balloon to be removed from patient and a new sheath placed.Stent was removed from patient.

• Brand Name: VALEO® BALLOON EXPANDABLE BILIARY STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 10065031
• Report Number: 10065031
• Device Sequence Number: 14390946
• Product Code: FGE
• UDI-Device Identifier: 00801741000652
• UDI-Public: (01)00801741000652(17)211022(10)GFDW3239
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2020
• Report Date (Section F): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EV06181CD
• Device Catalogue Number: EV06181CD
• Device Lot Number: GFDW3239
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 04/21/2020