MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-05 for DUALOK BREAST LESION LOCALIZATION WIRE LW0077 manufactured by Bard Peripheral Vascular, Inc..
[76764273]
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.
Patient Sequence No: 1, Text Type: N, H10
[76764274]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00562 |
| MDR Report Key | 6613190 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-05 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-06-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUALOK BREAST LESION LOCALIZATION WIRE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | GDF |
| Date Received | 2017-06-05 |
| Catalog Number | LW0077 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-05 |