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

Model Number	475201
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).
Event or Problem Description
It was reported that post placement of a breast localization wire, an artifact was allegedly found on mri images.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One medical image (mri) was provided and reviewed.The provided image is a sagittal mr image with gradient artifact that is more than expected around the localization wire.The artifact is more than expected.Based on the image review, the reported failure is confirmed as the image review demonstrated an artifact.A definitive root cause for the alleged artifact could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 04/2023).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.H3 other text : device not returned.
Event or Problem Description
It was reported that post placement of a breast localization wire, an artifact was allegedly found on mri images.There was no reported patient injury.

• 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: 11655902
• Report Number: 2020394-2021-00854
• Device Sequence Number: 11610016
• Product Code: GDF
• UDI-Device Identifier: 00801741079917
• UDI-Public: (01)00801741079917
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Model Number: 475201
• Device Catalogue Number: 475201
• Device Lot Number: REES2580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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