MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-16 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidary Of Icad.
[4829648]
Patient underwent an apbi (accelerated partial breast radiation) procedure for breast cancer on friday, (b)(6) 2014. The balloon applicator device was implanted in the patient. The patient returned to the physician's office on monday, (b)(6) 2014 for the continuation of the apbi procedure, at which time, the balloon was found in a ruptured state. The balloon was removed from the patient on (b)(6) 2014 and a replacement balloon was implanted. The apbi procedure was completed and the patient sustained no injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12351189]
The failure analysis of the device found that the balloon had a longitudal tear along the seam of the balloon where the mold parting line exists. The mold parting line is formed by the fabrication process of the balloon and is not a manufacturing defect of the process. There was no evidence of any contaminant particles or tooling damage that might have contributed to the balloon separating in this area. A lot history review found no anomalies of possible consequence to this incident. All product manufactured for the lot complied with specifications for product release. Manufacturing lot investigated: 820714. Xoft internal complaint tracking number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2014-00004 |
| MDR Report Key | 4093275 |
| Report Source | 05 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-08-25 |
| Date Mfgr Received | 2014-08-25 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-09-29 |
| 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 | MR. AL YOUNG |
| Manufacturer Street | 101 NICHOLSON LAN |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Manufacturer City | CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPLICATOR, SIZE 3-4 CM |
| Product Code | JAD |
| Date Received | 2014-09-16 |
| Returned To Mfg | 2014-09-08 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | 820714 |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 24 MO |
| 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. Required No Informationntervention | 2014-09-16 |