MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS LOCALIZATION WIRE; BIOPSY INSTRUMENT

Model Number	475201
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 475201 biopsy instrument allegedly had signal artifact on mri imaging.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• Brand Name: GHIATAS LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9200115
• Report Number: 2020394-2019-04035
• Device Sequence Number: 10839221
• Product Code: GDF
• UDI-Device Identifier: 00801741079917
• UDI-Public: (01)00801741079917
• 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): 10/16/2019

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: 475201
• Device Catalogue Number: 475201
• Device Lot Number: REDQ0895
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1