MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-05-14 for XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 110 XP1100 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[19971749]
A patient underwent treatment for breast cancer using the xoft electronic brachytherapy system. The treating facility reported that the patient may not have received the prescribed dose of radiation delivered by the brachytherapy controller. The facility indicated that the controller was inadvertently unplugged to reposition the unit in the operating room after the x-ray source of the controller was calibrated to an air kerma strength of 127,557u. After the controller was restarted, the source was re-calibrated and read an air kerma strength value of 86,977u which was 31. 8% less than the previous calibration. The device operating instructions alert the user to not use the source if the calibrated value for the air kerma strength differs from the previous calibration by more than + 5%. Facility personnel were aware of the operating instructions but proceeded with the procedure using the source that was recalibrated at an air kerma value of 86,997u. After the procedure was performed and upon the recommendation by the manufacturer's service personnel, the facility recalibrated the source and observed that the air kerma strength was within + 5% of the first calibration performed (127,557u). Based on this observation, it was believed that the patient may have received a radiation dose beyond the prescribed level for the procedure. The manufacturer's field service personnel ran mock treatments at the customer's site using a field service x-ray source on the controller and all accessories and found no operation anomalies. The x-ray source, well chamber, and electrometer were returned to the manufacturer for further evaluation. The patient was evaluated by the treating physician several weeks after the treatment and showed no acute symptoms of radiation exposure. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20180950]
The evaluation of the brachytherapy controller unit (s/n (b)(4)) source usage log showed a 31. 8% decrease in the air kerma strength from the first calibration of the x-ray source (s/n (b)(4)), consistent with the operator's claim that a significant reduction in the air kerma strength was observed. The x-ray source was retested by the manufacturer using the same test system for the certification of the sources. The device was per cycled 103 times and showed no significant variation in output. The controller, well chamber and electrometer were retested and determined to be within a fraction of 1% of their original performance measurements. No other incidences of this nature were ever reported to the manufacturer. Based on these findings, no definitive root cause was determined for the significant change in the air kerma strength observed by the user. The brachytherapy controller unit, x-ray source, well chamber, and electrometer all performed to specification as verified by the manufacturer. A manufacturing device history review found no related anomalies involving the manufacturing of the controller, x-ray source and accessories.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2014-00003 |
| MDR Report Key | 3913109 |
| Report Source | 00 |
| Date Received | 2014-05-14 |
| Date of Report | 2014-05-14 |
| Date of Event | 2014-04-16 |
| Date Mfgr Received | 2014-04-16 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AL YOUNG |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | CONTROLLER |
| Product Code | JAD |
| Date Received | 2014-05-14 |
| Returned To Mfg | 2014-04-23 |
| Model Number | 110 |
| Catalog Number | XP1100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-14 |