MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-21 for SAVI 8-1 manufactured by Cianna Medical.
[4502485]
A savi breast catheter used for accelerated partial breast irradiation had 2 struts (#2 and 9) that failed to deploy in the pt's breast. As a result of the malfunction the catheter was removed and treatment for breast cancer was delayed. This is the third savi apbi breast catheter in the last 90 days that has failed to perform as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036260 |
| MDR Report Key | 3835670 |
| Date Received | 2014-05-21 |
| Date of Report | 2014-05-20 |
| Date of Event | 2014-05-16 |
| Date Added to Maude | 2014-05-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAVI |
| Generic Name | BREAST CATHETER |
| Product Code | JAQ |
| Date Received | 2014-05-21 |
| Model Number | 8-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL |
| Manufacturer Address | ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-21 |