MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-02 for CONTURA * manufactured by Senorx, Inc..
[950030]
The balloon applicator had blood in the radiation ports. This is not appropriate since it can contaminate the high dose rate brachytherapy device which is used on multiple patients at a time. The manufacturer's representative was present. This is a known manufacturing error that has occurred in 2 out of 1000 cases. The balloon was pulled and replaced with a different type of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1187867 |
| MDR Report Key | 1187867 |
| Date Received | 2008-10-02 |
| Date of Report | 2008-10-02 |
| Date of Event | 2008-09-22 |
| Report Date | 2008-10-02 |
| Date Reported to FDA | 2008-10-02 |
| Date Added to Maude | 2008-10-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTURA |
| Generic Name | CATHETER, BRACHYTHERAPY, BREAST |
| Product Code | IWJ |
| Date Received | 2008-10-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1221637 |
| Manufacturer | SENORX, INC. |
| Manufacturer Address | 11 COLUMBIA, SUITE A ALISO VIEJO CA 92656 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-02 |