MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-29 for SAVI CATHETER 6-1 SAVI 6-1 manufactured by Cianna Medical.
[4064157]
A savi applicator used for accelerated partial breast irradiation malfunctioned allowing fluid to leak into one of the high dose rate (hdr) iridium-192 (ir192) source channels. Because of the leak that channel was not used for the treatment. The fluid if allowed to come in contact with the hdr ir192 source can cause damage to the hdr unit and potentially the ir192 source such that it could shear off due to rust formation. If the fluid contaminates the hdr unit, it could cause delay in treatment for the pt as well as other hdr pts while the unit is rebuilt and the source prematurely exchanged. The desired treatment volume and dose were achieved using the remaining channels. Dates of use: (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034134 |
| MDR Report Key | 3603317 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-28 |
| Date of Event | 2014-01-17 |
| Date Added to Maude | 2014-02-04 |
| 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 CATHETER 6-1 |
| Generic Name | BREAST CATHETER |
| Product Code | JAQ |
| Date Received | 2014-01-29 |
| Model Number | SAVI 6-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-01-29 |