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 2019-08-27 for GHIATAS LOCALIZATION WIRE 477201 manufactured by Bard Peripheral Vascular, Inc..
[155784001]
The lot number of the device was provided. The device history records are currently under review. The return of the sample is pending. The photo review is currently underway review. The investigation is currently underway. (expiry date: 02/2022).
Patient Sequence No: 1, Text Type: N, H10
[155784002]
It was reported that post placement of a localization wire, an artifact allegedly was found on mri imaging. It was further reported that the procedure was completed with another device. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-02984 |
| MDR Report Key | 8937675 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-27 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2019-08-02 |
| Date Added to Maude | 2019-08-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| 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 | GHIATAS LOCALIZATION WIRE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | GDF |
| Date Received | 2019-08-27 |
| Model Number | 477201 |
| Catalog Number | 477201 |
| Lot Number | REDQ4074 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2019-08-27 |