MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-23 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[4368409]
Patient underwent an apbi (accelerated partial breast irradiation) procedure for breast cancer. The balloon applicator placed in the patient was found deflated several days after the device was placed. An evaluation of the device fund that it would not hold pressure and leaked. A new device was placed in the patient and the procedure was completed without further incident. No injury was sustained by the patient as an outcome of this event. Internal complaint tracking number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11787493]
The failure analysis of the device found a small cut in the shaft near the location of the hub. The cut appeared to be attributed to a sharp tool, and the device leaked in this area of the cut. A device lot history review confirmed that the device was manufactured to specifications and that there were no anomalies of the lot indicative of the device failure. Furthermore, as part of the apbi procedure, the device is verified for correct placement and sustainment of pressure. The device leak was found several days after implant. Based on the compilation of these findings it is reasoned that the device failure is attributable to use error. Internal complaint tracking number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2014-00002 |
| MDR Report Key | 3810914 |
| Report Source | 05 |
| Date Received | 2014-03-23 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-03-03 |
| Date Mfgr Received | 2014-03-03 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-06-02 |
| 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 94534 |
| Manufacturer Country | US |
| Manufacturer Postal | 94534 |
| Manufacturer Phone | 4084931541 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2014-03-23 |
| Returned To Mfg | 2014-03-10 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | 820908 |
| Device Expiration Date | 2015-11-01 |
| 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 | 1. Required No Informationntervention | 2014-03-23 |