MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidary Of Icad, Inc..
[118392910]
The device failure analysis confirmed that an object of unknown origin had breached the external surface of the balloon triggering a longitude tear extending between the proximal and distal ends of the balloon. A device lot history review confirmed no related anomalies. All manufacturing specifications had been met for the lot released. The indicated failure mode is an inherent risk of the intraoperative (iort) procedure and conforming with the risk profile defined for the device. The failure rate for balloon ruptures not attributed to user error is (b)(4) based on (b)(4) devices shipped from january 1, 2016 through june 30, 2018, which encompasses the manufacturing release date of the device lot reviewed.
Patient Sequence No: 1, Text Type: N, H10
[118392911]
The 3-4 cm balloon applicator of the brachytherapy procedure for a patient undergoing intraoperative radiation treatment for breast cancer was found with a longitude tear that enabled the saline solution from the balloon to escape. The indicated finding was discovered after radiation treatment was delivered and the balloon applicator explanted from the patient, therefore indicating that twice the indicated radiation dose may have been delivered. The procedure was completed and no apparent injury was sustained by the patient. The device was returned to the manufacturer for failure analysis. Complaint tracking # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2018-00002 |
| MDR Report Key | 7820781 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2018-12-18 |
| Date Added to Maude | 2018-08-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPLICATOR, SIZE 3-4 CM, SPERICAL, PRODUCT CODE: JAD |
| Product Code | JAD |
| Date Received | 2018-08-27 |
| Returned To Mfg | 2018-08-13 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | 01710227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDARY OF ICAD, INC. |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-27 |