MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720342 AB2034 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[30240276]
A device failure analysis could not be performed, as the device was discarded by the hospital following the procedure. The manufacturer (xoft) performed a lot history review on 10/21/2015 and found no anomalies relating to the reported event. All specifications for the manufacturing of the device had been met. The device ifu (instructions for use) appropriately documented the precautionary instructions alerting the user of the device to not use sharp instruments (i. E. , syringes, forceps, etc. ) in the vicinity of the balloon. No further action was taken for the investigation of this complaint.
Patient Sequence No: 1, Text Type: N, H10
[30240277]
A female patient underwent brachytherapy treatment for breast cancer. The 3-4 cm balloon applicator of the brachytherapy treatment system was inserted in the patient's breast to initiate the procedure. While the balloon was inserted, the physician injected a dose of lidocaine in the area of the balloon insertion. After the therapeutic dose of radiation was delivered, the balloon was extracted from the cavity of the patient, at which point it was observed that only 5 cc of saline was present in the balloon when 30 cc of saline had originally filled the device. The treating facility stated that the balloon might have been punctured by the syringe during the injection, thus decreasing the volume of the balloon expanding the patient's cavity and possibly exposing the patient to a higher dose of radiation treatment. The physician re-sectioned the affected area of the patient as a precautionary measure. The patient experienced no adverse symptoms following the procedure and was subsequently released. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2015-00001 |
| MDR Report Key | 5186251 |
| Date Received | 2015-10-28 |
| Date of Report | 2015-10-17 |
| Date of Event | 2015-10-13 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2015-10-28 |
| 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 |
| Reporter Occupation | PHYSICIST |
| 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 |
| Date Received | 2015-10-28 |
| Model Number | 720342 |
| Catalog Number | AB2034 |
| Lot Number | 503485 |
| Device Expiration Date | 2017-08-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-10-28 |