MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-14 for RADIADYNE manufactured by Radiadyne, Llc.
[1951231]
Pt in ct to have marker placed in lung mass to be used in cyberknife treatment. The fiducial marker 22-gauge needle was advanced under ct guidance into the lung mass, and the marker was deployed. The needle was removed. Post placement imaging showed that the marker had withdrawn with the needle into the soft tissues of the paraspinal muscles. A new marker was placed w/o difficulty. The needles/markers come pre-packaged and do not require set up. It is felt that the needle/marker and the needle "pusher" were not aligned properly, prior to packaging, thus causing the "pusher" to pull the needle/marker back out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020316 |
| MDR Report Key | 2065773 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-04-14 |
| Date of Event | 2011-04-05 |
| Date Added to Maude | 2011-04-26 |
| 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 | RISK MANAGER |
| 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 | RADIADYNE |
| Generic Name | GOLD ANCHOR, FIDUCIAL MARKER |
| Product Code | MIJ |
| Date Received | 2011-04-14 |
| Lot Number | JA2701 |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIADYNE, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-14 |