MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-05-01 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720331 AB2045 manufactured by Xoft, A Subsidary Of Icad, Inc..
[74168099]
A device failure analysis was not performed. The hospital facility had discarded the device. User error appears to be at fault. According to the reporting facility, the physician had inadvertently punctured the balloon with a surgical instrument while the device was implanted in the patient. No active therapy (or radiation) was being applied at the time. The device was extracted and replaced with a new device and the patient's procedure was completed without further incident. No patient injury was sustained. A manufacturing lot history search of the device found no related anomalies. Further, the device ifu (instructions for use) contains the following precautionary statements in relation to using surgical instruments near the vicinity of the balloon applicator: "exercise caution when handling the applicator balloon as well as the applicator shaft both prior to and during implantation. Silicone is susceptible to damage by sharp instruments, forceps, surgical clips and excessive pushing and pulling. " "exercise extreme caution when using the applicator in conjunction with surgical marking clips to avoid puncture of the device. Surgical clips which protrude into the treatment area may increase the risk of damage to the balloon when it is inserted and inflated. " the indicated incident had occurred on (b)(6) 2014 as part of the device clinical study, but was reported to xoft quality assurance on (b)(6) 2017. The late reporting of this incident was due to a communication fault occurring at the clinical site. Corrective action has since been implemented and the required personnel have been retrained.
Patient Sequence No: 1, Text Type: N, H10
[74168100]
The xoft 4-5 cm balloon applicator was inadvertently punctured by the physician while the device was implanted in the patient undergoing intraoperative radiation therapy (iort). No radiation therapy was being applied. The device was removed from the patient and replaced with a new device. No patient injury was sustained and the procedure was completed without further incident. Xoft internal complaint reference #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2017-00001 |
| MDR Report Key | 6535501 |
| Report Source | USER FACILITY |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-27 |
| Date of Event | 2014-09-04 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2017-05-01 |
| 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 |
| 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 4-5 CM |
| Product Code | IYC |
| Date Received | 2017-05-01 |
| Model Number | 720331 |
| Catalog Number | AB2045 |
| Lot Number | 820985 |
| Device Expiration Date | 2016-04-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-05-01 |