MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-09 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[18855713]
Pt underwent brachytherapy radiation treatment for breast cancer. Device was implanted on (b)(6) 2013. When pt returned to the physician's office on (b)(6) 2013 to begin radiation treatment, the balloon applicator was found ruptured. The device was explanted from the pt and replaced with a new device. The radiation treatment was completed without subsequent incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19276098]
Complete device failure analysis is pending. Supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2013-00006 |
| MDR Report Key | 3624226 |
| Report Source | 05 |
| Date Received | 2013-12-09 |
| Date of Report | 2013-12-05 |
| Date of Event | 2013-11-11 |
| Date Mfgr Received | 2013-11-11 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-04-01 |
| 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 | OT |
| 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 | 2013-12-09 |
| Returned To Mfg | 2013-11-21 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | 820896 |
| Device Expiration Date | 2015-10-31 |
| 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. Other | 2013-12-09 |