MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-06 for AXXENT E BX BALLOON APPLICATOR KIT AB2060 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[94250705]
A 3-4 cm balloon applicator kit failed intraoperatively. The valve would not allow the surgeon to inflate or deflate the balloon. Malfunction caused a delay in the case. No harm reached the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073811 |
| MDR Report Key | 7095785 |
| Date Received | 2017-12-06 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-10-17 |
| Date Added to Maude | 2017-12-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXXENT E BX BALLOON APPLICATOR KIT |
| Generic Name | AXXENT E BX BALLOON APPLICATOR KIT |
| Product Code | JAD |
| Date Received | 2017-12-06 |
| Model Number | AB2060 |
| Lot Number | 01707051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| 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. Required No Informationntervention | 2017-12-06 |