MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720340 AB2034 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[134454215]
Device failure analysis is still under investigation. Final report is pending. Device lot numbers, manufacturing, and expiration dates are given below: lot # 01810162 (2 devices), manufacture date: november 2018, expiration date: november 2021. Lot # 01811131 (1 device), manufacture date: december 2018, expiration date: december 2021.
Patient Sequence No: 1, Text Type: N, H10
[134454216]
Treating clinical site located in (b)(6), reported the failure of three 3-4 cm balloon catheters being used to treat patients undergoing intra-operative radiation therapy (iort) for breast cancer. The treating facility reported that two such devices ruptured in the patient while the physician attempted to inject sterile water into the device. The third device was being prepared to be used in a second patient but had ruptured while attempting to pre-inflate the device before being used in the patient. All three devices were returned to the manufacturer for failure analysis. Both patients sustained no injury and both patient procedures were completed with backup 3-4 cm balloon catheters from the manufacturer. Internal complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2018-00003 |
| MDR Report Key | 8282885 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-12-28 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2019-01-28 |
| 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 |
| Manufacturer G1 | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95134 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 720340 |
| Catalog Number | AB2034 |
| Lot Number | SEE NARRATIVE, SECTION H-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-28 |