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

Catalog Number	47920
Medical Device Problem Codes	Image Display Error/Artifact (1304); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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
It was reported that during a breast tissue marker placement, there was no specification on the packaging referring to mri.There was no reported patient injury.
Event or Problem Description
It was reported that during a breast tissue marker placement, there was no specification on the packaging referring to mri.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.However, the investigation is confirmed for the identified improper or incorrect procedure or method as an user issue was identified.An user issue may have contributed to the reported artifact, however, a definitive root cause for the reported image display error /artifact could not be determined based upon the provided information.Labeling review: a review of the bd ghiatas beaded breast localization wire instructions for use determined the product labeling documentation is adequate.Per the ghiatas beaded breast localization wire instructions for use (ifu), product codes with 475201, 477201, 479201, and 470201 may be placed under mri guidance as the reported product code 47920 was not supposed to be operated under mri.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.

• Brand Name: GHIATAS
• Common Device Name: BREAST LOCALIZATION WIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21572047
• Report Number: 2020394-2025-00316
• Device Sequence Number: 8940357
• Product Code: GDF
• UDI-Device Identifier: 00801741079832
• UDI-Public: (01)00801741079832(11)240806(17)270531(10)REJT2398
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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 Catalogue Number: 47920
• Device Lot Number: REJT2398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown