MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-29 for BALLOON APPLICATOR KIT - 3-4 SPHERICAL AB2034 manufactured by Xoft, Inc..
[16093125]
Balloon leak during brachytherapy of the breast is an anticipated event. The balloon in this event was evaluated including a review of the dhr, visual inspection, (b)(4) analysis of the material. Investigation revealed leak was due to puncture from a sharp object, most likely the allis forceps used during implantation of the balloon applicator. Labeling warns user to exercise caution when handling the device both prior to and during implantation. Labeling also states that the device material (silicone) is susceptible to damage by sharp instruments and excessive pushing and pulling. Patient was not harmed.
Patient Sequence No: 1, Text Type: N, H10
[16124587]
A 3-4 cm spherical balloon ruptured post implantation. The balloon was successfully explanted, and the incident did not result in a patient injury. Balloon rupture is an anticipated adverse event per the instructions for use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2011-00021 |
| MDR Report Key | 2096900 |
| Report Source | 07 |
| Date Received | 2011-04-29 |
| Date of Report | 2011-04-29 |
| Date of Event | 2011-04-07 |
| Date Mfgr Received | 2011-04-07 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2011-07-19 |
| 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 Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON APPLICATOR KIT - 3-4 SPHERICAL |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2011-04-29 |
| Returned To Mfg | 2011-04-11 |
| Model Number | AB2034 |
| Catalog Number | AB2034 |
| Lot Number | 800325 |
| Device Expiration Date | 2012-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | 345 POTRERO AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-29 |