MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DUALOK LOCALIZATION WIRE

Catalog Number	LW0057
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a breast biopsy procedure using dualok wire.Post the procedure, the mammogram showed that the hook was snapped into two.It was further reported that during deployment under us dualok, it was difficult to be seen, hence the snapping was not noticeable.Furthermore, the hook was removed with a prolonged stay at the surgery.No coaxial needle was used and the procedure was completed using another device.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: 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.Section a through f - the information provided 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.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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 image was provided and reviewed.Right breast cc mammogram was performed following wire localization.The submitted image shows a wire within the lateral right breast.The wire does not contain the hook at the distal tip.About 1-2 cm medial to this, there is a small linear piece of metal which is allegedly the tip of the previously described wire.This would indicate that the hook portion of the wire fractured during placement.Dualok wires are made to be flexible, and fracture of the wire is extremely rare.Fracture should not occur under typical conditions and if that is what occurred it would likely be due to a defective wire.It is also possible that this particular wire was bent very sharply, which could cause a fracture.In this case, an additional wire was placed in order to localize and subsequently remove the fractured fragment.It also would have been fine to leave the small wire tip in the breast, as it would not cause any detrimental effects to the patient.Based on the image review, the reported event can be confirmed.Therefore, the investigation is confirmed for the reported break as hook portion of the wire fractured during placement.A definitive root cause for the break 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.B5, d4 (medical device lot number), d4 (unique identifier (udi) #), g3, h1, h6 (patient, method, result, conclusion).Section a through f ¿ the information provided 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent mammogram biopsy procedure using dualok wire.Post the procedure, the mammogram showed the hook was snapped into two.It was further reported that during deployment under us dualok, it was difficult to be seen, hence snapping was not noticeable.No coaxial needle was used and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: DUALOK LOCALIZATION WIRE
• Common Device Name: 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: 23665059
• Report Number: 2020394-2025-01999
• Device Sequence Number: 21060312
• Product Code: GDF
• UDI-Device Identifier: 00801741079733
• UDI-Public: (01)00801741079733(17)270930(10)REJX0579
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LW0057
• Device Lot Number: REJX0579
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female