MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Ghiatas; Breast Localization Wire

Catalog Number	47720
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient was scheduled to undergo a localization wire placement procedure using a ghiatas breast localization wire.Prior to the procedure, foreign material was observed on the needle.The procedure was subsequently completed using an alternative device.There was no patient contact.
Additional Manufacturer Narrative
H11: 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.Two electronic photos were provided and reviewed.The first photo shows that a labeling information of the ghiatas which verifies and matches with tw details.The second photo shows that a wire clip and is expected to be positioned on the needle protector packaging.Based on the photo review the reported event cannot be confirmed.Therefore, the investigation is unconfirmed for the reported device contamination with chemical or other material, as no foreign material was observed in the provided photo.A definitive root cause for the reported device contamination with chemical or other materials could not be determined based upon the provided information labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (method, result, conclusion) section a through f: the information provide by bd represents all 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 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50065835
• Report Number: 2020394-2026-01957
• Device Sequence Number: 21422786
• Product Code: GDF
• UDI-Device Identifier: 00801741079818
• UDI-Public: (01)00801741079818(17)281031(10)REKY0552
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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: 47720
• Device Lot Number: REKY0552
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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