MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DUALOK BREAST LESION LOCALIZATIONS WIRE; BREAST LOCALIZATION WIRES

Model Number	LW0107
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event involving 2 devices on the same patient.A review of the event indicated that model lw0107 breast localization wire experienced both difficulty to advance and difficulty to remove on both devices.This was received from one source.The event involved a patient with no reported injury.The patient is female, and age and weight were not reported.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for the wire advancement issue and wire removal issue as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event involving 2 devices on the same patient.A review of the event indicated that model lw0107 breast localization wire experienced both difficulty to advance and difficulty to remove on both devices.This was received from one source.The event involved a patient with no reported injury.The patient is female, and age and weight were not reported.

• Brand Name: DUALOK BREAST LESION LOCALIZATIONS WIRE
• Common Device Name: BREAST LOCALIZATION WIRES
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8485527
• Report Number: 2020394-2019-00229
• Device Sequence Number: 11130685
• Product Code: GDF
• UDI-Device Identifier: 00801741079757
• UDI-Public: (01)00801741079757
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: No Information
• Device Model Number: LW0107
• Device Catalogue Number: LW0107
• Device Lot Number: RECS1578
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1