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

Catalog Number LW0057

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2024).H11: 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 Description

It was reported that during an ultrasound guided breast biopsy procedure, the wire was allegedly fractured at the skin surface and there was no undue movement of force.The procedure was completed using another device.There was no reported patient injury.

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 image provided was reviewed.The images show a fractured dualok wire.The distal portion of the wire is within the outer right breast, entirely within the breast, traversing a mass (presumably the intended target).The proximal portion of the wire is coiled on the skin at the entrance location.Upon discussion wire localization is performed prior to surgery in order to help the surgeon locate the area to be excised in the operating room.The wire is placed by the radiologist, with the tip of the wire at the site to be excised and the proximal portion of the wire remaining outside the breast so that the surgeon can follow the wire from the skin to the excision location.In this case, it appears that the wire fractured at some point during placement, leaving the tip of the wire in the breast at the excision site, but without a visible proximal end for the surgeon to see outside the breast.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 placed under an unusual amount of stress or perhaps bent very sharply, which could cause a fracture.In this case, the wire fracture occurred very close to the skin so it likely was very easy for the surgeon the find the wire in the operating room and perform the surgery as planned.If the fracture occurred more distally, a second wire could be placed and both wires could be removed during surgery.Based on the image review the reported break is confirmed as the fracture was noted in the wire.A definitive root cause for the alleged 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.H10: d4 (expiration date: 03/2024), g3, h6 (method).H11: 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 Description

It was reported that during an ultrasound guided breast biopsy procedure, the wire was allegedly fractured at the skin surface and there was no undue movement of force.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: DUALOK LOCALIZATION WIRE
• Type of Device: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18325323
• MDR Text Key: 330488637
• Report Number: 2020394-2023-01258
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: LW0057
• Device Lot Number: REFR4145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1