MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTEM

Model Number	E4115
Medical Device Problem Codes	Failure to Calibrate (2440); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model e4115 enspire system allegedly failed to calibrate and experienced unintended movement.This report was received from one sources.There was no patient involvement for this event.

• Brand Name: ENCOR ENSPIRE SYSTEM
• Common Device Name: ENSPIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8525470
• Report Number: 2020394-2019-00482
• Device Sequence Number: 14170401
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: No Information
• Device Model Number: E4115
• Device Catalogue Number: E4115
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1