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

Catalog Number	LW0107
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Excessive Tear Production (2235)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy into normal tissue, the device allegedly failed to deploy and was difficult to remove from the patient.A tear in the patient's tissue occurred as a result of the removal of the device.It was further reported that a planned secondary intervention was performed and another device was used to complete the biopsy.The patient is stable.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure modes.Investigation summary: one dualok localization wire and introducer cannula was returned for evaluation.Visual inspection identified a slight bends on the braded wire.The bends were not originally reported and it is unknown if shipping/handling contributed to the observed condition; therefore, the finding was consider an incidental finding.The investigation is inconclusive for both difficult to advance and difficult to remove, as a functional evaluation could not be performed due to the return condition of the sample and the specific circumstances of the procedure (i.E.Patient tissue), could not be replicated.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy into normal tissue, the wire allegedly failed to advance within the cannula and was difficult to remove from the patient.A tear in the patient's tissue occurred as a result of the removal of the device.It was further reported that a planned secondary intervention was performed and another device was used to complete the biopsy.The patient is stable.

• Brand Name: DUALOK BREAST LESION LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7807552
• Report Number: 2020394-2018-01528
• Device Sequence Number: 13775679
• Product Code: GDF
• UDI-Device Identifier: 00801741079757
• UDI-Public: (01)00801741079757
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: LW0107
• Device Lot Number: RECR0358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 70