MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-19 for ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM 720332 AT2056 manufactured by Xoft, A Subsidiary Icad, Inc..
[3843716]
Pt underwent a brachytherapy radiation procedure for breast cancer. Following the procedure, the pt arrived home and called the physician stating that she heard the balloon of the applicator device pop and felt fluid leaking out. She then removed the bandages, and while doing so, the applicator device fell out. The device was returned to the physician's office by the pt's son with the device broke in half at the balloon applicator shaft with the stylet still inside. The pt gave no explanation for how the device was broke in half. The pt returned to the physician's office for follow-up but no medical intervention was performed, nor did the pt sustain any serious injury from the incident. In a subsequent interview, it was stated by the physician that the pt was not in risk of any harm. It was also mentioned that the pt was in an advanced state of dementia making her not a good candidate for the procedure. The physician and the pt decided to not continue the procedure. Note: no pt injury was reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11135643]
Device failure analysis: device was received by the manufacturer completely severed at the balloon applicator shaft. It appeared that the device was mechanically pulled apart at the point of separation. No explanation was provided by the physician or the pt on why the device was returned in this state, or if any defect located in this section of the device had contributed to the incident. A microscopic inspection of the fractured sections found no manufacturing anomalies. Furthermore, the balloon was pressurized to full volume for 24-hours and showed no indication of leaks. A manufacturing lot history review found no anomalies related to the reported complaint. Based on the outcome of this investigation, no failure was confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2013-00004 |
| MDR Report Key | 3327444 |
| Report Source | 05,07 |
| Date Received | 2013-08-19 |
| Date of Report | 2013-08-13 |
| Date of Event | 2013-07-30 |
| Date Mfgr Received | 2013-07-30 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-11-14 |
| 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 | ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2013-08-19 |
| Returned To Mfg | 2013-08-02 |
| Model Number | 720332 |
| Catalog Number | AT2056 |
| Lot Number | 820739 |
| Device Expiration Date | 2014-12-31 |
| 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 ICAD, INC. |
| Manufacturer Address | SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-19 |