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

Model Number	477201
Medical Device Problem Codes	Signal Artifact/Noise (1036); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicates that model 477201 localization wire allegedly produced artifacts during imaging.This information was received from one source.This involved a patient with no consequences.The patient was reported as (b)(6) years old, weighing 114 pounds, the gender of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The event information was reassessed and the device codes were updated.Sixteen lot samples were returned; the investigation is inconclusive as the conditions of use could not be replicated.A medical image was provided and was inconclusive for the reported signal artifact malfunction.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicates that model 477201 localization wire allegedly produced artifacts during imaging.This information was received from one source.This involved a patient with no consequences.The patient was reported as 86 years old, weighing 114 pounds, the gender of the patient was 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: 9200122
• Report Number: 2020394-2019-04037
• Device Sequence Number: 13529411
• Product Code: GDF
• UDI-Device Identifier: 00801741079924
• UDI-Public: (01)00801741079924
• 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,Followup
• Report Date (Section B): 01/06/2020

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: 477201
• Device Catalogue Number: 477201
• Device Lot Number: REDQ4074
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1