MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-10 for SAVI 8-1 CATHETER manufactured by Cianna Medical.
[4181775]
Savi 8-1 breast catheter device has two obstructed channels that would not allow the passage of the hdr source to deliver planned radiation dose for breast cancer treatment. The treatment plan was rerun eliminating the two obstructed channels. A satisfactory radiation dose distribution was achieved using the remaining channels. The treatment was delayed one day due to this problem. Reason for use: breast cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034481 |
| MDR Report Key | 3629195 |
| Date Received | 2014-02-10 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-01-24 |
| Date Added to Maude | 2014-02-18 |
| 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 | 0 |
| 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 8-1 CATHETER |
| Generic Name | BREAST CATHETER |
| Product Code | JAQ |
| Date Received | 2014-02-10 |
| Returned To Mfg | 2014-02-07 |
| Model Number | SAVI 8-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2014-02-10 |