MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-17 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidary Of Icad.
[53446982]
The failure analysis of the 3-4 cm balloon confirmed a longitudinal tear along the length of the device axis consistent with the balloon rupturing, which can occur if the balloon is overinflated, damaged by a sharp surgical instrument, or if the patient's anatomy places excessive stress on the balloon. A manufacturing lot history review found no anomalies relating to the failure of the device. Thus, no root cause was confirmed.
Patient Sequence No: 1, Text Type: N, H10
[53446983]
A patient underwent intraoperative radiation treatment (iort) for breast cancer. The treatment facility reported that during the procedure, the balloon catheter had ruptured while implanted in the patient, thus allowing sterile water to spill out. No active radiation therapy was being applied. The balloon was removed from the patient and a new balloon was inserted. The patient procedure was completed with no further incident and there was no injury sustained by the patient. The damaged device was returned to xoft for failure analysis. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2016-00002 |
| MDR Report Key | 5884444 |
| Date Received | 2016-08-17 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-07-20 |
| Date Mfgr Received | 2016-08-15 |
| Device Manufacturer Date | 2016-04-18 |
| Date Added to Maude | 2016-08-17 |
| 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 | 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 |
| Product Code | IYC |
| Date Received | 2016-08-17 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | 821201 |
| Device Expiration Date | 2018-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDARY OF ICAD |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-17 |