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

Catalog Number	47920
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided breast biopsy procedure, the breast positioning needle marker beads allegedly found to be fallen off.Reportedly, all the three marker beads that the needle contained were completely removed, and there was no residue in the patient's wound.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records was 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.H10: d4 (expiry date: 08/2025).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.Device not returned.
Additional Manufacturer Narrative
H10: this supplemental mdr is being submitted to report that mfr rpt# 2020394-2024-00355 was a duplicate record and was opened in error.The event details are being captured under complaint file #(b)(4) and was reported to the fda under mfr rpt# 2020394-2024-00278.H10: d4 (expiry date: 08/2025), g3.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 an ultrasound guided breast biopsy procedure, the breast positioning needle marker beads allegedly found to be fallen off.Reportedly, all the three marker beads that the needle contained were completely removed, and there was no residue in the patient's wound.There was no reported patient injury.

• 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: 18928240
• Report Number: 2020394-2024-00355
• Device Sequence Number: 21193781
• Product Code: GDF
• UDI-Device Identifier: 00801741079832
• UDI-Public: (01)00801741079832
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: REGW2764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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