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

Catalog Number	LW0077
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: review not performed as the lot number of the device was not provided.Visual inspection: inspection not performed as the sample was not provided.Functional/performance evaluation: evaluation not performed as the sample was not provided.Medical records review: review not performed as medical records were not provided.Image/photo review: review not performed as images/photos were not provided.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: general information and device description: the bard® dualok® breast lesion localization wire is a two-component device consisting of a needle cannula with integral female luer lock hub and a localization wire with dual locking elements at the distal tip.The bard® dualok® breast lesion localization wire is a disposable single patient use device and is available in various lengths.Indications for use: the bard® dualok® breast lesion localization wire is intended for use as a guide for directing surgical biopsies.Precautions: 1.This device should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.2.The introduction of the device into the body should be carried out under imaging control (ultrasound, x-ray, ct, etc.).Note: this product has not been tested for mr imaging compatibility.Been tested for mr imaging compatibility.3.Before using, inspect the device for damaged point, bent shaft or other imperfections that would prevent proper function.If the components are damaged or bent, do not use.Directions for use: 1.Inspect the package and product for damage and expiration date.If undamaged and unexpired, open the package and transfer the product onto the sterile field utilizing aseptic technique.2.Prior to use, determine the appropriate bard® dualok® localization wire required for the specific localization to be performed.Using aseptic technique, remove the wire/needle cannula from the package.Before using, inspect the wire/needle cannula for damaged tips, bent shafts, deformed locking elements or other imperfections that would prevent proper function.If the wire/needle cannula are damaged, bent or do not move together easily, do not use.Localization procedure: 1.While holding the cannula hub stationary, grasp the proximal end of the wire and slowly withdraw the dual locking elements into the distal tip of the cannula.The wire is fully withdrawn when the band of tight twists on the wire are visible outside the cannula hub.2.Identify the desired tissue entry location and advance the cannula into the tissue.If needed, use the reference markings on the cannula to determine placement depth.Stop advancing when the distal tip of the cannula is just proximal to the desired location.3.To set the wire locking elements, hold the needle cannula stationary while advancing the wire forward into the cannula hub.The locking elements are fully deployed when the band of tight twists on the wire are just inside the cannula locking hub.Repositioning or removal of bard dualok localization wire: 4.If the localization wire needs to be repositioned or removed, withdraw the locking elements into the needle cannula by holding the proximal end of the wire stationary and slowly advancing the needle cannula forward.The locking elements are fully withdrawn into the cannula when the bands of tight twists are visible outside the cannula hub.Then reposition the needle cannula to the desired location and re-set the locking element.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 a breast tissue localization wire placement, the cannula allegedly broke from the plastic hub.There was no reported patient injury.

• 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: 6613190
• Report Number: 2020394-2017-00562
• Device Sequence Number: 12737
• Product Code: GDF
• UDI-Device Identifier: 00801741079740
• UDI-Public: (01)00801741079740
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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: LW0077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1