MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-25 for MAMMOSITE RADIATION THERAPY SYSTEM MAMMOSITE SPHERICAL VARIABLE 5-6 APPLICATOR TRAY * manufactured by Cytyc Surgical Products Division (formerly Proxima Till 3-2005.).
[371463]
The patient arrived for simulation of their planned mammosite procedure. During the simulation, fluoroscopy revealed that the mammosite balloon had burst. The doctor was notified and the md came and removed the defective mammosite balloon. It appears to have been a clear tear. The md inserted a new mammosite balloon and a second simulation was completed. A few days later, the patient arrived for their first treatment. On the pre-treatment fluoroscopy, the replacement mammosite balloon was found to have burst. The patient reported hearing a popping sound over the weekend. Physicians were notified. Both physicians recommended removing the mammosite balloon and not reinserting at this time. The tear in the balloon looked clean. The wound was dressed and the patient was advised to continue on antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 610983 |
| MDR Report Key | 610983 |
| Date Received | 2005-05-25 |
| Date of Report | 2005-05-25 |
| Date of Event | 2005-05-09 |
| Report Date | 2005-05-25 |
| Date Reported to FDA | 2005-05-25 |
| Date Added to Maude | 2005-06-08 |
| 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 | MAMMOSITE RADIATION THERAPY SYSTEM |
| Generic Name | IMPLANT FOR RADIATION TREATMENT |
| Product Code | MOU |
| Date Received | 2005-05-25 |
| Returned To Mfg | 2005-05-09 |
| Model Number | MAMMOSITE SPHERICAL VARIABLE 5-6 APPLICATOR TRAY |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 600773 |
| Manufacturer | CYTYC SURGICAL PRODUCTS DIVISION (FORMERLY PROXIMA TILL 3-2005.) |
| Manufacturer Address | 2555 MARCONI DRIVE SUITE 220 ALPHARETTA GA 300054143 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-25 |